[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurodevelopmental-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurodevelopmental-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,46,74,110,150,182,205,233,258,297,333,360,386,408,440,463,493,517,551,576,603,626,646,668,699],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652875","the-effects-of-the-melillo-method-on-biopsychosocial-outcomes-in-school-age-children-100652875",false,"NCT07779889","The Effects of the Melillo Method® on Biopsychosocial Outcomes in School-Age Children","The Effects of the Melillo Method® on Biopsychosocial Outcomes in School-Age Children: A Pilot Randomized Delayed-Start Trial","Inclusion Criteria:\n\n* 8+ years old\n* Attends Roodhouse Elementary or North Greene Jr. High School\n* Screening SDQ-P Total Difficulties Score ≥17 and Total Impact Score ≥2\n\nExclusion Criteria:\n\n* History of Epilepsy\n* Diagnosis of Oppositional Defiance Disorder (ODD) or Conduct Disorder (CD)\n* Impairments that preclude standardized administration of the assessments and\u002For therapy (e.g., uncorrected visual or hearing loss, paralysis of the arms or legs)","ALL","8 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot study will test whether a school-based neurodevelopmental brain-training program, called the Melillo Method®, is feasible to deliver and study in elementary and middle school students who are struggling with behavior and learning. The study will enroll about 34 children ages 8 and older at two schools in Illinois. Children will be identified by teachers and school staff as needing extra support, and families will complete a brief questionnaire to confirm eligibility.\n\nChildren who qualify will be randomly assigned to start the program right away (24 weeks of sessions) or after a delay (12 weeks of sessions, starting partway through the study). This \"delayed-start\" design lets every enrolled child eventually receive the program while still allowing researchers to compare outcomes between children who started earlier versus later.\n\nThe program combines sensory stimulation (lights, gentle vibration, scent), rhythm-based exercises, primitive reflex integration activities, and balance\u002Fcoordination training, delivered by a trained clinician in small groups of two. Sessions occur three times per week for about 20 minutes each.\n\nResearchers will measure whether the study procedures are practical and acceptable. For example, how many eligible families enroll, how well families and teachers complete follow-up questionnaires, how well students tolerate the assessments, and how consistently families attend sessions. As a secondary goal, the study will explore whether children show changes in thinking skills, fine motor coordination, and emotional\u002Fbehavioral functioning, measured using standardized tools (the NIH Toolbox and the Strengths and Difficulties Questionnaire) completed by the children, their parents, and their teachers.\n\nThis is a feasibility study. It is not intended to prove that the program works, but rather to determine whether a larger, more rigorous trial is realistic and well-designed.",[27,28],"Social Behavior Disorders","Neurodevelopmental Disorders",[30,31,32],"Pilot Projects","Pediatrics","Melillo Method","NOT_YET_RECRUITING","2026-08-18",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2027-05",{"name":43,"class":44},"Life University","OTHER",2,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100467005","prevention-of-developmental-delay-and-xylitol-pddax-study-100467005","NCT05361122","Prevention of Developmental Delay and Xylitol (PDDaX) Study","Inclusion Criteria:\n\n* Child born during the PPaX trial\n* Enrollment age between 4-8 years old\n* Parental or legal guardian consent obtained\n* Willing to undergo 3 neurodevelopmental tests\n* Willing to travel to BCMF for neurodevelopmental assessment\n* Assent by the pediatric subject for participation in the study\n\nExclusion Criteria:\n\n* Parent or legal guardian cognitively unable to provide consent\n* Child unwilling to provide assent to participate in the study","4 Years",{"count":54,"type":21},1000,[24],"The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children.\n\nAdditionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes).\n\nThe researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.",[58,28],"Prematurity",[60,61,62,58],"Xylitol","Oral Health","Pregnancy","RECRUITING","2026-08-15",{"date":66,"type":37},"2026-08-19",{"date":68,"type":37},"2023-04-04",{"date":70,"type":21},"2027-09-30",{"name":72,"class":44},"University of Washington",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":73},"100531005","weighted-blankets-for-sleep-disturbance-among-children-with-adhd-100531005","NCT06194162","Weighted Blankets for Sleep Disturbance Among Children With ADHD","Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age 5-12 years (both included) at randomization.\n3. Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.\n4. Comorbidities are allowed.\n5. Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.\n6. If on ADHD medication or\u002Fand melatonin\u002Fsleep medication the dose must be stable, at least two weeks prior to enrollment.\n7. The child and caregiver have adequate mastery of the Danish language.\n\nExclusion Criteria:\n\n1. Have used any type of medical device class 1 weighted blanket before.\n2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).\n3. Another member of the household enrolled in the trial.","5 Years","12 Years",{"count":84,"type":21},340,[24],"Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.",[88,89,28,90,91,92,93],"Attention-deficit Hyperactivity","Attention Deficit Hyperactivity Disorder","Sleep Disturbance","Attention Deficit Disorder","Hyperkinetic Conduct Disorder","Attention-Deficit Hyperactivity Disorder, Unspecified Type",[95,96,97,98,90,99,100],"ADHD","weighted blanket","Children","Randomised controlled trial","ADD","Functional impairment","2026-08-12",{"date":103,"type":37},"2026-08-14",{"date":105,"type":37},"2024-01-01",{"date":107,"type":21},"2028-12-31",{"name":109,"class":44},"University Hospital Bispebjerg and Frederiksberg",{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100522340","phase-2-sertraline-vs-placebo-in-the-treatment-of-anxiety-in-children-and-adolescents-with-neurodevelopmental-disorders-100522340","NCT06081348","Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders","A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders","CALM","Inclusion Criteria:\n\n1. Outpatients 8-17 years of age, inclusive\n2. Females of child bearing potential who are sexually active and agree to use medically acceptable birth control throughout the study and at least one week post last dose of study drug.\n3. Meet Diagnostic and Statistical Manual of Mental Disorders - DSM-5 criteria for ASD, ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions.\n4. Meet DSM-5 criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Anxiety Disorder, Agoraphobia, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder, based on expert clinical interview, supported by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS; Kaufman et al., 2016). Other specified anxiety disorder is included to account for youth with impairing anxiety symptoms who may not meet criteria for one of the other anxiety disorders.\n5. Have a Clinician's Global Impression-Severity for anxiety (CGI-S; Guy, 1976)) score ≥ 4 (moderately ill) (inter-rater reliability will be done prior to initiation of enrollment, using videotapes of interviews and vignettes)\n6. If already receiving interventions, must meet the following criteria:\n\n   1. If receiving concomitant medications affecting behaviour, must be on a stable dose during the month prior to screening and will not electively modify ongoing medications for study duration\n   2. If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions\n7. Ability to complete assessments in English\n\nExclusion Criteria:\n\n1. Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)\n2. Previous treatment with sertraline, at an adequate dose (at least 100mg for 6 weeks, or lower dose and duration if not well-tolerated), associated with no response or significant-to-the-participant side effects.\n3. Received more than 2 previous appropriate trials of SSRIs with no adequate response\n4. Pregnant females or sexually active females on inadequate contraception\n5. Serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger participant. In addition diabetic patients on medications for glycemic control will be excluded as sertraline may interfere with glycemic control.\n6. Hypersensitivity to sertraline or any components of its formulation\n7. On Monoamine Oxidase Inhibitors or pimozide (as per product monograph)\n8. On concomitant medications known to significantly increase QT interval where this would result in unacceptable risk per Investigator judgment.\n9. Known congenital QT prolongation\n10. HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode or psychosis (as required by Health Canada)\n11. Unable to tolerate venipuncture\n12. Unable to swallow capsules\n13. Enrolled in another intervention study","17 Years",{"count":120,"type":21},130,[122],"PHASE2","There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.",[28,125,126,127,128,129,130,95,131,132,133,134,135,136,137,138,139],"Autism","Autism Spectrum Disorder","Fragile X Syndrome","Tuberous Sclerosis","22Q11 Deletion Syndrome","22Q11 Deletion","Tic Disorders","Tourette Syndrome","Tourette Syndrome in Children","Tourette Syndrome in Adolescence","ADHD - Combined Type","ADHD Predominantly Inattentive Type","ADHD, Predominantly Hyperactive - Impulsive","Anxiety","Anxiety Disorders","2026-07-24",{"date":142,"type":37},"2026-07-27",{"date":144,"type":37},"2024-09-16",{"date":146,"type":21},"2027-09",{"name":148,"class":44},"Holland Bloorview Kids Rehabilitation Hospital",7,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100648078","vippstar-g1-digital-early-intervention-for-visual-impairment-100648078","NCT07717671","VIPPSTAR-G1 Digital Early Intervention for Visual Impairment","VIPPSTAR-G1: A Multicenter Randomized Controlled Trial Evaluating a Caregiver-mediated Digital Intervention to Promote Visual Function and Neurodevelopment in Infants at Risk of\u002FWith Visual Impairment","VIPPSTAR-G1","Inclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment\n\n* Gestational age ≤32 weeks OR full-term\u002Fnewborns\\>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes)\n* NAVEG score ≥3\n* At least one neurological or neuroimaging abnormality:\n\n  * 3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings\n\nExclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment\n\n* Epileptic encephalopathy\n* Parents unable to understand local language\n\nInclusion Criteria: Study Sample 2 - Infants\u002FToddlers With Visual Impairment\n\n* Age ≤42 months\n* Diagnosis of peripheral or cerebral visual impairment\n* Moderate or severe visual impairment documented by standardized visual acuity testing Exclusion Criteria: Study Sample 2 - Infants\u002FToddlers With Visual Impairment\n* Age \\>42 months\n* Refractory epilepsy or epileptic encephalopathy\n* Participation in another interventional study within previous 12 months\n* Parents unable to understand local language","1 Day","42 Months",{"count":161,"type":21},150,[24],"Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental outcomes, but implementation of intensive interventions in routine clinical practice remains challenging. The VIPPSTAR-G1 study evaluates a caregiver-mediated digital intervention delivered through a dedicated platform designed to support visual and neurodevelopmental functions in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child\u002Fcaregiver-child relationship.\n\nThis multicenter, multinational, single-blind randomized controlled trial will enroll 102 newborns at risk of visual impairment and an additional exploratory pilot subgroup of 48 infants and toddlers with established visual impairment. Participants will be randomized to receive either the VIPPSTAR digital intervention plus standard care or standard care alone. Outcomes include visual acuity, smooth pursuit, additional neuro-ophthalmological functions, neurodevelopmental measures, adaptive functioning, language development, parental stress, quality of life, and feasibility of the digital intervention.",[165,166,28,58],"Visual Impairment","Cerebral Visual Impairment",[168,169,170,171],"visual impairment","early intervention","digital health","prematurity","2026-07-16",{"date":174,"type":37},"2026-07-21",{"date":176,"type":21},"2026-07-01",{"date":178,"type":21},"2028-06-30",{"name":180,"class":44},"Università degli Studi di Brescia",5,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100369906","evaluation-of-effectiveness-of-child-oriented-goal-setting-in-paediatric-rehabilitation-the-engage-approach-100369906","NCT04096430","Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)","Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis","Inclusion criteria are children with a diagnosed disability who:\n\n1. are between the ages of 5-12 years\n2. are able to engage in the goal-setting process (determined by therapists)\n3. are referred to PT and\u002For OT for a period of direct treatment\n4. speak English.\n\nChildren will be excluded from the trial if:\n\n1. the parent or guardian who attends therapy does not speak English\n2. the child has a diagnosis that suggests developmental regression\n3. the child has uncontrolled seizures (i.e., seizure within the past 2 months).",{"count":190,"type":21},96,[24],"Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.",[126,28,194],"Cerebral Palsy","2026-07-14",{"date":197,"type":37},"2026-07-15",{"date":199,"type":37},"2022-03-01",{"date":201,"type":21},"2026-08-31",{"name":203,"class":44},"University of Alberta",6,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":212,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":73},"100645526","dietary-pattern-intervention-for-neurodevelopment-in-preterm-infants-100645526","NCT07702734","Dietary Pattern Intervention for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)\n* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).\n* Corrected age of 6 months ± 7days at the time of enrollment.\n* No systemic antibiotic usage within 14 days prior to screening.\n* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.\n\nExclusion Criteria:\n\n* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).\n* Severe neurological disorders or structural brain injuries (e.g., Grade III\u002FIV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).\n* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).\n* Concurrent participation in other interventional clinical trials.\n* Planned long-term use of other commercial probiotic\u002Fprebiotic supplements outside the study protocol during the intervention period.\n* High risk of loss to follow-up (e.g., expected relocation).","6 Months",{"count":214,"type":21},116,[24],"The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants. The intervention lasts for 6 months and aims to promote the growth of endogenous beneficial gut bacteria through targeted complementary feeding. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids and tryptophan metabolites), and systemic inflammatory markers.",[218,28,219],"Preterm","Dysbiosis",[221,222,223,224,225],"Dietary Pattern","Prebiotics","Gut-Brain Axis","Neonatal Antibiotic Exposure","Preterm Infants","2026-07-09",{"date":195,"type":37},{"date":176,"type":21},{"date":230,"type":21},"2027-12-31",{"name":232,"class":44},"Fudan University",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":240,"targetDuration":242,"studyType":243,"phases":4,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":73},"100575750","natural-history-study-of-gemin-5-related-neurodevelopmental-disorder-100575750","NCT06776341","Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder","Retrospective and Longitudinal Prospective Natural History Study of GEMIN5-Related Neurodevelopmental Disorder","Inclusion Criteria:\n\n* Individuals with molecularly confirmed GEMIN5 biallelic mutations, ages 0 years and above\n\nExclusion Criteria:\n\n* none",{"count":241,"type":21},500,"26 Years","OBSERVATIONAL","This study will include a comprehensive retrospective chart review and a longitudinal prospective observational natural history study to characterize the phenotypic spectrum of GEMIN5-Related Neurodevelopmental Disorder. We aim to define the trajectory of this ultra-rare disease, core clinical features, characteristics at disease onset and diagnosis, neurological symptomatology, and neuroimaging findings over time. In this study, biological specimens (serum) will also be collected in a biorepository for translational research purposes.",[246,247,28],"SMN Complex Proteins","GEMIN5 Protein, Human",[249,28],"GEMIN5","2026-07-07",{"date":226,"type":37},{"date":253,"type":37},"2025-07-07",{"date":255,"type":21},"2050-12",{"name":257,"class":44},"University of Pittsburgh",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":81,"studyType":243,"phases":4,"briefSummary":270,"conditions":271,"keywords":281,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100472474","rett-syndrome-registry-100472474","NCT05432349","Rett Syndrome Registry","Rett Syndrome Real World Data Observational Registry","RSR","Inclusion Criteria:\n\n* Male or female with a pathologic loss of function alteration of MECP2\n\nExclusion Criteria:\n\n* Male or female with a gain of function alteration of MECP2, including those with MEPC2 duplication or triplication","0 Years","99 Years",{"count":269,"type":21},3000,"The Rett Syndrome Registry is a longitudinal observational study of individuals with MECP2 mutations and a diagnosis of Rett syndrome. Designed together with the IRSF Rett Syndrome Center of Excellence Network medical directors, this study collects data on the signs and symptoms of Rett syndrome as reported by the Rett syndrome experts and by the caregivers of individuals with Rett syndrome. This study will be used to develop consensus based guidelines for the care of your loved ones with Rett syndrome and to facilitate the development of better clinical trials and other aspects of the drug development path for Rett syndrome.",[272,273,274,275,276,277,278,279,28,280],"Rett Syndrome","Rett Syndrome, Atypical","Genetic Disease","Genetic Diseases, X-Linked","Intellectual Disability","Neurobehavioral Manifestations","Neurologic Manifestations","Neurologic Disorder","Nervous System Diseases",[282,283,284,285,286],"Rett syndrome","MECP2","Neurodevelopmental disorder","Registry","Natural History Study","2026-06-26",{"date":289,"type":37},"2026-06-30",{"date":291,"type":37},"2022-08-02",{"date":293,"type":21},"2028-07",{"name":295,"class":44},"International Rett Syndrome Foundation",19,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":303,"sex":17,"minAge":304,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":316,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100551076","the-genetics-navigator-evaluating-a-digital-platform-for-genomics-health-services-100551076","NCT06455384","The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services","Inclusion:\n\n* Adult patients (18 years of age or older) who are referred to participating clinicians at Mount Sinai Hospital for clinical genetic testing.\n* Parents\u002Flegal guardians (18 years of age or older) of pediatric patients who are referred to participating clinicians at SickKids for clinical genetic testing.\n\nExclusion:\n\n* Known not to be eligible for clinical genetic testing in Ontario\n* Requires urgent clinical genetic testing or prenatal genetic testing\n* Not fluent in English (speaking and reading)",true,"18 Years",{"count":306,"type":21},170,[24],"Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results. We have previously developed and tested an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) to be used for genetic testing decision making, and have now developed the Genetics Navigator (GN), a patient-centred e-health navigation platform for end-to-end genetic service delivery. The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered genetic testing. Results of this trial will be used to establish whether the GN is effective to use in practice. If effective, GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse of services. These are concerns policy makers seek to address through the triple aims of health care1. This study represents a significant advance in personalized health by assessing the effectiveness of this novel, comprehensive e-health platform to ultimately improve genetic service delivery, accessibility, patient experiences, and patient outcomes.",[310,311,312,313,28,314,315],"Cardiac Conditions","Connective Tissue Diseases","Retinal Disease","Epilepsy in Children","Cancer","Polyposis",[317,318,319,320,321,322],"Genomic Sequencing","Randomized Controlled Trial","Clinical Utility","Personal Utility","Decision Aid","Incidental Findings","2026-06-19",{"date":325,"type":37},"2026-06-24",{"date":327,"type":37},"2025-10-28",{"date":329,"type":21},"2027-07",{"name":331,"class":44},"Unity Health Toronto",3,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":303,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":73},"100491653","platform-for-the-prospective-mother-child-study-of-the-determinants-of-neurodevelopmental-disorders-100491653","NCT05681923","Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders","Platform for the Prospective Mother-child Study of the Determinants of Autism Spectrum Disorder and Neurodevelopmental Disorders Neurodevelopmental Disorders","MARIANNE","INCLUSION CRITERIA:\n\nGeneral inclusion criteria (High risk and Low risk cohorts)\n\nMother:\n\n* Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea,\n* Have at least one biological child of 24 months or older,\n* At least 18 years of age\n\nFather:\n\n* Be the biological father of the unborn child,\n* At least 18 years of age\n\nUnborn Child:\n\n\\- Have a woman study participant as mother.\n\nSpecific inclusion criteria for the High risk cohort:\n\n* Autistic sibling: refers to the biological child(ren) of the mother and\u002For father participating in the study and being the parent(s) of the unborn child\n* Be at least 24 months old and less than 18 years old,\n* Have a confirmed diagnosis of Autism Spectrum Disorder based on medical records. If in doubt, the SRS-2 (Social Responsiveness Scale for Adults) and PEDS-DM (Parents' Evaluation of developmental status) questionnaires will be completed. Only children with positive scores on one of these questionnaires will be included after validation of the diagnosis by an expert committee,\n* In case of several children with Autism Spectrum Disorder based in the siblings, only the last born will be included.\n\nRemarks:\n\n* Autism Spectrum Disorder siblings resulting from a medically assisted procreation are eligible provided that part of the genetic heritage is common to that of the mother or father of the unborn child participating in the study.\n* If the father does not live with the mother of the unborn child, his participation is not required and does not preclude the participation of other family members.\n\nEXCLUSION CRITERIA:\n\nGeneral non-inclusion criteria (High risk and Low risk cohorts):\n\nFather and mother:\n\n* Unable to understand French or the study questionnaires\n* Participant on protective measures (guardianship or curatorship) or deprived of liberty by judicial or administrative decision, or subject to a legal protection measure\n* Not affiliated to a social security system\n* Refusal to participate. In the case of consent given for the born and unborn child, the consent must be given by the person(s) with parental authority.\n* Live at a distance from the recruitment center incompatible with follow-up.\n\nSpecific non-inclusion criteria for the Low risk cohort:\n\nMother and\u002For father of unborn child:\n\n\\- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder",{"count":342,"type":21},7320,"Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. They are often associated and have a significant impact on daily functioning at school and at home.\n\nThe rate of people affected by neurodevelopmental disorders including autism spectrum disorder have increased significantly over the past 20 years. Improved screening only partly explains this evolution.\n\nA genetic predisposition plays an important role in the occurrence of these disorders, however, current scientific data suggest a multifactorial origin. Exposures such as those related to the use of pesticides, air pollution or the presence of endocrine disruptors in our diet could be involved in the genesis of neurodevelopmental disorders, particularly during intrauterine life, a period of great vulnerability.\n\nThe current diagnostic pathways for autism rarely enable the early identification of babies at risk. Without early detection and timely targeted intervention, these children have a poor health outcome and do not reach their full potential.\n\nThe general objective of the MARIANNE cohort is to constitute a French research infrastructure dedicated to research on the biological and environmental determinants of neurodevelopmental disorders including autism.\n\nThis cohort is based on the follow-up of 1200 families with already a child affected by an autism spectrum disorder, which implies a high risk of neurodevelopmental disorders including autism spectrum disorder for the siblings, and of 500 families from the general population with no excess risk of neurodevelopmental disorders. The total number of subjects to be included (mother, father, unborn child and ASD sibling for the HR group) is thus 6300.\n\nThe inclusion of these families will be at the beginning of a new pregnancy and the follow-up will be carried out from the second trimester of pregnancy until the children are 6 years old, the age at which the diagnosis of neurodevelopmental disorders is possible.\n\nBiological, clinical, social and environmental data will be collected at different stages of the follow-up and will be included into a large database.",[126,28],[346,347,348,349,350],"exposome","child development","genome","risk factors","prenatal cohort","2026-06-18",{"date":353,"type":37},"2026-06-22",{"date":355,"type":37},"2023-04-19",{"date":357,"type":21},"2034-03",{"name":359,"class":44},"University Hospital, Montpellier",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":303,"sex":17,"minAge":367,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":73},"100634691","individual-neurophysiological-sensory-profiles-in-people-with-and-without-neurodevelopmental-disorders-100634691","NCT07542977","Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders","SensAUry","Inclusion Criteria:\n\n* Social security affiliation\n* Free and written informed consent from the participants (Neurotypical Adults, NDD Adults without judicial protective measures), or their tutor or legal representant(s) (other participants)\n* Age between 6 and 12 years included (Children) or between 18 and 45 years included (Adults)\n* For NDD participants: NDD diagnosis by a qualified medical professional, according to DSM-4, DSM-5, ICD-10 or ICD-11 criteria\n\nNon-inclusion Criteria:\n\n* Psychotropic medication perturbing EEG recording\n* Drugs pertubing peripheral neurophysiological measures\n* Non-corrected visual or auditory troubles\n* Known neurological or psychiatric conditions (at the exclusion of NDD for NDD participants)\n* Epilepsy\n* Inclusion in another ongoing medical protocol\n* For Neurotypical participants: NDD diagnosis\n* For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion\n\nExclusion Criteria:\n\n* Participants with no data to evaluate Outcome 1","6 Years","45 Years",{"count":370,"type":21},200,"The goal of this observational study is to evaluate intra-individual neurophysiological variability in children and adults with and without NeuroDevelopmental Disorders (NDD), for several sensory modalities and types of stimulation. The main hypotheses are:\n\n* NDD participants and children exhibit higher intra-individual variability than other participants\n* intra-individual neurophysiological variability is correlated to behavioral, psychological and learning profiles\n\nParticipants in this study will:\n\n* be recorded for EEG and other neurophysiological parameters while exposed to sensory stimulations, to quantify sensory neurophysiological variability\n* perform behavioral tests and fill out questionnaires, to establish the behavioral and psychological profile\n* train for perceptual learning, to measure learning abilities\n\nThese evaluations will be split in 3 visits spread on a maximum of 3 months, and training for learning will be done at home in between 2 visits.",[28],[374,375,376],"Sensory","Neurophysiology","Profile","2026-06-12",{"date":379,"type":37},"2026-06-16",{"date":381,"type":37},"2026-05-07",{"date":383,"type":21},"2028-06-15",{"name":385,"class":44},"University Hospital, Tours",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":304,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":73},"100582945","homelessness-and-prevalence-of-neurodevelopmental-disorders-100582945","NCT06869915","Homelessness and Prevalence of Neurodevelopmental Disorders","Prevalence of Neurodevelopmental Disorders in a Homeless Population - Pilot Study","PRECA'TND","Inclusion Criteria:\n\n* Homeless people sheltered in accommodation and social rehabilitation centers\n* Over 18 years of age\n* Who speak French\n* who have given then written informed consent\n\nExclusion Criteria:\n\n\\- Every person who hasn't given their written informed consent.","90 Years",{"count":161,"type":21},[24],"Introduction \\& Central question: Psychiatric disorders are highly prevalent in the homeless population, however neurodevelopmental disorders are also at risk of leading to homelessness (Churchard et al., 2018; Casey et al., 2020). Research on this topic is poor in France. This research aims to study the prevalence in France of 3 neurodevelopmental disorders (NDDs) in a homeless population (Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Intellectual Developmental Disorder).\n\nMethods \u002F approach: A 2 phase approach will be used including a screening phase and a diagnosis phase. This research is a pilot study that will include 150 homeless people, over 2 years. The assessment involves combining the results from standardised self-report tools, direct observation and informant-report, thus guaranteeing an objective and thorough diagnosis. This approach gives a better picture of actual behaviour but also a better understanding of the person's development.\n\nOUTCOME: This study will give insight on how to better understand the profile of the homeless population in France, and the prevalence of autism in this population. It will also bring valuable knowledge on how autism and other NDDs can impact one's path in life and lead to homelessness. The results can help develop targeted cares and measures for homeless people with NDDs.",[28],[400],"homelessness","2026-06-10",{"date":377,"type":37},{"date":404,"type":37},"2026-03-09",{"date":70,"type":21},{"name":407,"class":44},"Hôpital le Vinatier",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":415,"minAge":304,"maxAge":416,"enrollmentInfo":417,"targetDuration":419,"studyType":243,"phases":4,"briefSummary":420,"conditions":421,"keywords":426,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":45},"100436511","neuraxial-labor-analgesia-and-offspring-neurodevelopment-100436511","NCT04964206","Neuraxial Labor Analgesia and Offspring Neurodevelopment","Impact of Maternal Neuraxial Labor Analgesia on Offspring Neurodevelopment. A Multicenter, Prospective, Longitudinal Cohort Study","Inclusion Criteria:\n\n1. Primiparae between 18 and 35 years of age with term single cephalic pregnancy;\n2. Undergo regular prenatal examination in the study centers;\n3. Preparing to deliver vaginally.\n\nExclusion Criteria:\n\n1. History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists);\n2. History of diseases involving the hypothalamic-pituitary-adrenal axis;\n3. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.\n4. Presence of contraindications to vaginal delivery;\n5. Other reasons that are considered unsuitable for study participation.","FEMALE","35 Years",{"count":418,"type":21},4645,"24 Months","How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring neurodevelopment.",[422,423,424,425,28],"Pregnant Women","Labor Pain","Analgesia, Epidural","Infants",[427,428,429,425,430],"Pregnant women","Labor pain","Neuraxial labour analgesia","Neurodevelopmental disorders","2026-06-05",{"date":433,"type":37},"2026-06-09",{"date":435,"type":37},"2022-10-14",{"date":437,"type":21},"2028-12",{"name":439,"class":44},"Dong-Xin Wang",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":446,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":73},"100640203","probiotics-supplementation-for-neurodevelopment-in-preterm-infants-100640203","NCT07617181","Probiotics Supplementation for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","23 Weeks","25 Weeks",{"count":214,"type":21},[24],"The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids \\[SCFAs\\], and systemic inflammatory markers.",[452,28,219],"Premature Birth",[454,223,224,225],"Probiotics","2026-05-23",{"date":457,"type":37},"2026-06-01",{"date":459,"type":21},"2026-06",{"date":461,"type":21},"2027-12",{"name":232,"class":44},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":45},"100435641","perinatal-covid-19-infection-no-pathway-and-minipuberty-100435641","NCT04952870","Perinatal Covid-19 Infection, NO Pathway, and Minipuberty","Exploratory Multicenter Observational Study to Assess the Outcome of Infants With Perinatal SARS-COV-2 Infection and Its Link With the NO Pathway: the Minipuberty Hypothesis","miniNO-COVID","Inclusion Criteria:\n\n* Group 1 : Newborn infants (24 to 41 weeks gestational age) or young infants (\\\u003C 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille with perinatal COVID-19 infection defined by:\n\n  * Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy;\n  * Post-natal COVID-19 infection: newborn or young infants (\\\u003C 3 months) with positive PCR test in pharynx or stools as part of their treatment.\n* Group 2 : Newborn infants (24 to 41 weeks gestational age) or young infants (\\\u003C 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille for severe cardiorespiratory diseases requiring inhaled NO treatment.\n* Group 3 : The control group without perinatal COVID-19 infection and no inhaled NO treatment will be matched to the two other groups on age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks), on respiratory failure (yes\u002Fno).\n* No inclusion in another ante- or post-natal trial;\n* Written consents from both parents.\n* Social security affiliation\n\nExclusion Criteria:\n\n* Preterm birth less than 24 weeks gestational age.\n* Severe brain lesions: bilateral and extensive periventricular leukomalacia, intracranial hemorrhage grade 3 or 4;\n* One or both of the parents is unable to read or understand French language, or refuse to participate","3 Months",{"count":473,"type":21},180,"Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. Among the various pathogenic features related to COVID-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. Altered minipuberty together with NO deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth",[476,28],"Newborn, Infant, Disease",[478,479,480,481,482,483],"Perinatal COVID","newborn","minipuberty","HPG axis","nitric oxide","neurodevelopmental outcome","2026-05-19",{"date":486,"type":37},"2026-05-20",{"date":488,"type":37},"2022-11-03",{"date":490,"type":21},"2026-11",{"name":492,"class":44},"University Hospital, Lille",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":73},"100622746","effectiveness-of-the-copca-program-in-infants-at-risk-of-neurodevelopmental-disorders-100622746","NCT07387627","Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders","Effectiveness of the Coping With and Caring for Infants With Special Needs Program in Infants at Risk of Neurodevelopmental Disorders. A Comparison With Conventional Pediatric Physiotherapy Models and Parent Training","COPCA","Inclusion Criteria:\n\n* Infants at risk of neurodevelopmental disorders.\n* Participation in pediatric physiotherapy and\u002For Early Intervention programs at the time of study inclusion, regardless of the reference center.\n* Corrected age under 12 months at the time of recruitment.\n\nExclusion Criteria:\n\n* Infants with confirmed neurodevelopmental disorders at the time of inclusion.\n* Presence of additional medical conditions requiring complex medical or surgical interventions that could interfere with participation in the study (e.g., recent or planned surgery).\n* Severe family socio-communicative difficulties that limit participation in coaching sessions (e.g., significant language barriers).","12 Months",{"count":503,"type":21},40,[24],"The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving development in infants at risk of neurodevelopmental disorders, as well as empowering their families.\n\nThis study will include infants younger than 12 months of corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy services, together with their parents or primary caregivers.\n\nThe main questions this study aims to answer are:\n\nDoes the COPCA® program improve motor development and functional abilities in infants at risk of neurodevelopmental disorders more than conventional pediatric physiotherapy or parent education?\n\nDoes the COPCA® program increase family empowerment and improve parents' perception of the care they receive compared with traditional intervention models?\n\nThe researchers will compare outcomes across four study groups:\n\nIn-person COPCA® intervention\n\nOnline COPCA® intervention\n\nParent education group\n\nConventional pediatric physiotherapy group\n\nParticipants will be randomly assigned to one of the four groups. The intervention period will last 6 months, with assessments conducted at the start of the study, during the intervention, and during follow-up.\n\nInfants will take part in age-appropriate daily activities and play situations. Parents or caregivers will actively participate in the intervention sessions and will be supported in learning how to promote their child's development during everyday routines.\n\nThe study will assess infant motor development, functional abilities, overall development, family empowerment, and parents' perception of family-centered care using validated assessment tools and interviews. The results of this study may help improve early intervention strategies for infants at risk of neurodevelopmental disorders and support more family-centered approaches to care.",[28,507],"Neurodevelopmental Disorders and Developmental Abnormalities","2026-04-28",{"date":510,"type":37},"2026-04-29",{"date":512,"type":37},"2026-02-10",{"date":514,"type":21},"2027-06-01",{"name":516,"class":44},"University of Seville",{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":304,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":535,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":549,"locationsCount":73},"100636006","a-scalable-trans-diagnostic-intervention-targeting-adolescent-agency-supported-by-conversational-ai-agencia-100636006","NCT07560072","A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)","A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI","AGENCIA","Inclusion Criteria:\n\n* Adolescents aged 12 to 18 years at enrollment.\n* Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).\n* Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.\n* Ability to use digital materials through a personal device and basic reading skills in Spanish.\n* Availability to attend assessments and participate in the intervention and follow-up schedule.\n* Informed consent from caregivers and assent from the adolescent.\n\nExclusion Criteria:\n\n* Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).\n* Score of \"Severe\" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying\u002Fsocial problems).\n* Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive\u002Fexpressive language difficulties, motor limitations preventing device use).\n* Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.\n* Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.",{"count":526,"type":21},465,[24],"The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.\n\nParticipants will be randomly assigned to one of three groups:\n\nAGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.\n\nDigital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.\n\nThe main research questions are:\n\nDoes AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?\n\nParticipants will:\n\n* Complete three structured sessions depending on their assigned group.\n* Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.\n* Receive brief phone calls during follow-ups to support questionnaire completion.\n\nA total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.",[530,28,531,532,533,534],"Irritability","Impulsivity","Emotional Dysregulation","Distress, Emotional","Distress, Psychological",[536,537,538,539,430,540,541,542],"Adolescents","Randomized controlled trial","Personal Agency","Digital health intervention","Family accommodation","Conversational AI","Trans diagnostic interventions","2026-04-23",{"date":545,"type":37},"2026-04-30",{"date":547,"type":21},"2026-04-01",{"date":107,"type":21},{"name":550,"class":44},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":158,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":73},"100489887","kidsheart-and-brain--early-eeg-surgery-congenital-heart-disease-predict-onset-of-neurodevelopmental-disorders-100489887","NCT05658965","KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders","Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement","KHB","Inclusion Criteria:\n\n* Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.\n* Child with congenital cardiopathy with necessity to be operated before 1 year old.\n\nExclusion Criteria:\n\n* Child with no necessity of surgery before 1 year old.\n* Medical history of cardiac surgery.\n* Refusal of consent by the parents.\n* No social security.\n* Child not operated on the CHU of LILLE.","1 Year",{"count":561,"type":21},50,"Congenital cardiopathy are frequent malformations (1\u002F100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.\n\nThe identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.\n\nOn the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.",[28,564],"Congenital Cardiomyopathy",[566,28,564,567],"EEG","Orality Disorders","2026-04-21",{"date":570,"type":37},"2026-04-24",{"date":572,"type":37},"2022-10-10",{"date":574,"type":21},"2026-10-13",{"name":492,"class":44},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":73},"100626718","characterization-of-social-cognition-profiles-in-children-and-adolescents-with-neurodevelopmental-disorders-a-clinical-study-using-a-multidimensional-battery-100626718","NCT07439276","Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery","COGSO","Inclusion Criteria:\n\n* Children and adolescents aged 8 to 16 years\n* Proficiency in French (native language)\n* Information and consent obtained from those holding parental authority, and agreement from the child or adolescent\n* No recently modified (\\\u003C6 weeks) psychotropic medication from the following categories: antidepressants, anxiolytics, antipsychotics, psychostimulants, mood stabilizers.\n* IQ above 70 (WISC-V)\n* Criteria for Neurodevelopmental Disorders: Diagnosis of Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder (according to DSM-5)\n* Multiple complex developmental disorder : Symptoms characteristic of a neurodevelopmental disorder without meeting all the criteria for a specific disorder and presence of multiple complex developmental disorder criteria with at least 5 elements from the specified categories.\n\nExclusion Criteria:\n\n\\- Having an active neurological disorder (e.g., active epilepsy)","16 Years",{"count":585,"type":21},100,[24],"In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children.\n\nThe challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder.\n\nTherefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.",[28,126,89,589],"Atypical Neurodevelopmental Disorder",[430,126,89,591,592,593],"Atypical neurodevelopmental disorder","Social cognition","Children and teenagers","2026-04-13",{"date":596,"type":37},"2026-04-16",{"date":598,"type":37},"2026-04-08",{"date":600,"type":21},"2029-04",{"name":602,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":73},"100532460","patterns-of-neurodevelopmental-disorders-100532460","NCT06213090","Patterns of Neurodevelopmental Disorders","Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders","Inclusion Criteria:\n\nNeurodevelopmental delays Clinical visit at an Rossignol Medical Center\n\nExclusion Criteria:\n\n\\-",{"count":54,"type":21},"The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.",[28,126,613,614,615,616,617,618],"Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection","Pediatric Acute-Onset Neuropsychiatric Syndrome","Down Syndrome","Epilepsy","Mitochondrial Encephalomyopathies","Cerebral Folate Deficiency",{"date":596,"type":37},{"date":621,"type":37},"2024-02-01",{"date":623,"type":21},"2030-12-31",{"name":625,"class":44},"Richard Frye",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":642,"leadSponsor":644,"locationsCount":4},"100630786","high-depth-exome-sequencing-on-dna-from-a-salivary-sample-by-mouth-smear-100630786","NCT07492199","High Depth Exome Sequencing on DNA From a Salivary Sample by Mouth Smear.","Evaluation of the Diagnostic Performance of High-depth Exome Sequencing on DNA From a Salivary Sample by Oral Smear in the Etiological Assessment of Patients With a Syndromic Neurodevelopmental Disorder or an Intellectual Development Disorder and for Which the Sequencing of the Genome on Blood Has Proved Inconclusive.","SEPASA","Inclusion Criteria:\n\n* Patient with syndromic neurodevelopmental disorder (NDD) or intellectual developmental disorder (IDD)\n* Trio genome sequencing on blood inconclusive\n* Men and women\n* All ages\n* No objection to participating in the study\n* Affiliation with a French social security system or beneficiary of such a system\n\nExclusion Criteria:\n\n* Pregnant women and nursing mothers\n* Persons deprived of their liberty by judicial or administrative decision; persons undergoing compulsory psychiatric care; persons admitted to a health or social care facility for purposes other than research\n* Subjects who are in the exclusion period of another study or listed in the \"national volunteer registry\"\n* Genetic cause identified in the preliminary etiological assessment\n* Phenocopy: other likely non-genetic cause of TND (perinatal anoxia, infection, trauma, etc.)\n* Patients without health insurance\n* Patients unlikely to cooperate with the study and\u002For anticipated low cooperation by the investigator",{"count":561,"type":21},"Despite technological advances, a genetic etiology has been identified in only about 50% to 60% of patients with Neurodevelopmental disorders (NDDs), with a higher diagnostic yield in the syndromic NDD and IDD subgroups. However, identifying a precise etiological diagnosis is essential to optimize patient care, clarify their prognosis, consider targeted therapies, refer families to appropriate resources and support, and provide genetic counseling to relatives. The tests typically offered as part of the etiological assessment of syndromic NDDs and IDD include DNA microarray analysis, testing for fragile X syndrome and genome sequencing from a blood sample. When this assessment remains negative, the cause usually remains unknown.\n\nMosaic genomic abnormalities (or post-zygotic variations) are a common cause of negative results in current diagnostic genetic tests and represent a field of research that has yet to be fully explored outside of skin disorders. Identifying mosaic genomic abnormalities remains technically complex due to the difficulty of detecting low levels of mosaicism and limited access to the tissue of interest when the variation is absent from blood tissue.\n\nHigh-depth exome sequencing is the technique of choice for detecting low levels of mosaicism. In the case of NNDs, as the affected tissue is not available, the buccal epithelium is an interesting alternative to blood, as it is easily accessible and inexpensive.\n\nThe objective of our study is to evaluate the diagnostic yield of high-depth exome sequencing technology on a DNA extracted from a buccal swab in the etiological assessment of patients with IDD or syndromic NDD whose reference analysis (genome sequencing on blood) proved inconclusive.",[28,637],"Intellectual Developmental Disorder","2026-04-09",{"date":640,"type":37},"2026-04-14",{"date":547,"type":21},{"date":643,"type":21},"2029-04-01",{"name":645,"class":44},"Centre Hospitalier Universitaire de Besancon",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":303,"sex":17,"minAge":653,"maxAge":367,"enrollmentInfo":654,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":656,"conditions":657,"keywords":658,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":666,"locationsCount":73},"100631624","the-relationship-between-reaction-time-and-motor-skills-in-children-with-pervasive-developmental-disorders-100631624","NCT07503106","The Relationship Between Reaction Time and Motor Skills in Children With Pervasive Developmental Disorders","The Relationship Between Reaction Time and Motor Skills in Preschool Children With Pervasive Developmental Disorders","Inclusion Criteria:\n\n* Being between 3 and 6 years of age\n* For typically developing children, having no diagnosis of any neurodevelopmental or orthopedic disorder\n* Having a diagnosis of Pervasive Developmental Disorder made by a child psychiatrist or pediatric neurologist\n* Absence of visual, auditory, or motor impairments that would prevent administration of the Peabody Developmental Motor Scales-2 (PDMS-2) and the Catch Pad reaction test\n* Having sufficient cognitive ability to understand and follow simple instructions during the assessment\n\nExclusion Criteria:\n\n* In the typically developing group, having a diagnosis of Attention Deficit -Hyperactivity Disorder (ADHD) or any other neurodevelopmental disorder\n* Presence of additional neurological or orthopedic conditions, apart from Pervasive Developmental Disorder, that would interfere with test administration\n* Visual or hearing impairments severe enough to prevent test administration\n* History of orthopedic trauma or surgery within the last 6 months that could affect motor performance\n* Presence of significant behavioral problems","3 Years",{"count":655,"type":21},30,"This study examines whether the relationship between reaction time and motor skills differs between children aged 3-6 with pervasive developmental disorders and typically developing peers. It aims to determine the direction and strength of this relationship in children with developmental disorders and compare it with that of typically developing children, thereby providing evidence on how cognitive processing speed and motor performance interact in early childhood under developmental disorder conditions.",[28],[659,660,661],"Reaction time","Peabody Developmental Motor Scales","Pervasive Developmental Disorders",{"date":594,"type":37},{"date":664,"type":21},"2026-04",{"date":459,"type":21},{"name":667,"class":44},"Yeditepe University",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":676,"enrollmentInfo":677,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":679,"conditions":680,"keywords":684,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":73},"100578123","motor-voice-assessment-in-infants-mami-100578123","NCT06807203","Motor-voice Assessment in Infants (MAMI)","Spontaneous Motor-voice Assessment in Infants Using Video and Audio Recordings.","MAMI","Inclusion Criteria:\n\n* gestational age of 24 0\u002F7 - 41 6\u002F7,\n* admitted to the NICU,\n* medically stable by 40 weeks of gestation (including off ventilator support),\n* born to mothers 18 - 43 years old at the time of birth,\n* one parent fluent in English.\n\nExclusion Criteria:\n\n* diagnosis of a genetic syndrome (e.g. Trisomy 21),\n* musculoskeletal deformity,\n* failed hearing screen.","10 Days",{"count":678,"type":21},46,"The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants.. The main questions it aims to answer are:\n\nIdentify voice factors among infants with newborn-detectable risk. Identify association between individual characteristics (Gestational age at birth, global function, motor-function) and voice factors.\n\nExamine unique features of voice production that are present in infants with high-risk for Cerebral Palsy (CP).\n\nParticipants will be asked to upload a 3-minute videos of their child at term-age, 3.5-, and 9-months of age.\n\nAt the 3.5-month and 9-month time point parents can choose to attend an optional in-person assessment with their child.",[681,682,683,28,126],"Cerebral Palsy Infantile","Pre-Term","Motor Delay",[685,686,687,688,689],"Digital health,","Motor assessment,","voice assessment,","cognition","neurodevelopment,","2026-03-24",{"date":692,"type":37},"2026-03-27",{"date":694,"type":37},"2025-10-22",{"date":696,"type":21},"2030-01-28",{"name":698,"class":44},"Ohio State University",{"id":700,"slug":701,"hasResults":12,"nctId":702,"briefTitle":703,"officialTitle":704,"acronym":705,"eligibilityCriteria":706,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":82,"enrollmentInfo":707,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":708,"conditions":709,"keywords":729,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":754,"lastUpdatePostDateStruct":755,"startDateStruct":757,"completionDateStruct":759,"leadSponsor":761,"locationsCount":73},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.",{"count":585,"type":21},"This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[28,710,507,711,712,713,681,714,715,126,716,717,718,719,720,721,722,723,724,725,726,727,728],"Neurodevelopmental Disorders (NDD)","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Autism Spectrum Disorder (ASD","Hypoxic Ischemic Encephalopathy","Hypoxic Ischemic Encephalopathy (HIE)","Traumatic Brain Injury (TBI)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","22q11.2 Deletion Syndrome","Sensorimotor Integration",[730,731,732,733,734,735,736,737,738,739,740,741,742,743,744,745,746,747,28,748,749,750,751,752,753],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Sensory Integration","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Early Intervention","Cognitive Therapy","2026-03-19",{"date":756,"type":37},"2026-03-25",{"date":758,"type":37},"2026-03-01",{"date":760,"type":21},"2036-12-30",{"name":762,"class":44},"Healing Hope International"]