[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-intensive-care-unit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-intensive-care-unit":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,79,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100648834","maternal-sensory-interventions-in-newborns-100648834",false,"NCT07725094","Maternal Sensory Interventions in Newborns","The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial","MSI","Inclusion Criteria:\n\n* Gestational age between 35 and 42 completed weeks.\n* Birth weight between 2,000 and 4,200 grams.\n* Clinically stable newborn admitted to the neonatal intensive care unit.\n* Spontaneous breathing without the need for mechanical ventilation.\n* Not receiving sedative medications.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Five-minute Apgar score \\\u003C4.\n* Requirement for advanced resuscitation after birth.\n* Presence of a major congenital anomaly.\n* Requirement for invasive intervention involving the head region.\n* Diagnosed central nervous system dysfunction or neurological disorder.\n* Presence of severe postnatal medical complications that may affect study outcomes.\n\nExclusion Criteria (during the research):\n\n* The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.\n* A parent or legal guardian withdraws consent for the newborn's participation in the study.",true,"ALL","35 Weeks","42 Weeks",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.",[29,30],"Neonatal Intensive Care Unit","Hospitalized Newborn",[32,33,34,35,36,29,37,38,39],"Bispectral Index","Kangaroo Care","Lullaby","Maternal Sensory Intervention","Newborn","Physiological Parameters","Randomized Controlled Trial","Sleep-Wake States","NOT_YET_RECRUITING","2026-07-24",{"date":43,"type":44},"2026-07-27","ACTUAL",{"date":46,"type":23},"2026-08-15",{"date":48,"type":23},"2026-12-30",{"name":50,"class":51},"Kirsehir Ahi Evran Universitesi","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":17,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100647927","the-effect-of-gentle-human-touch-and-stimulus-reduction-on-pain-and-comfort-during-heel-blood-collection-in-premature-newborns-100647927","NCT07715682","The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 32 and 36+6 weeks\n* Written informed consent obtained from parents\n\nExclusion Criteria:\n\n* Infants with serious medical conditions that may affect study parameters\n* Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)","32 Weeks","37 Weeks",{"count":62,"type":23},60,[26],"Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.",[66,29,67,68],"Premature","Touch","Nursing Care","RECRUITING","2026-07-15",{"date":72,"type":44},"2026-07-20",{"date":74,"type":44},"2026-04-20",{"date":76,"type":23},"2026-12",{"name":78,"class":51},"Kubra Nur Kabakcı Sarıdağ",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":52},"100571911","critical-care-optimized-pediatric-and-neonatal-quantitative-neuromonitoring-100571911","NCT06726408","Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring","Critical Care Optimized Pediatric Quantitative EEG","COPeQ","Inclusion Criteria :\n\n* Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring. The same patient may be included multiple times.\n* Written non-opposition from legal representatives.\n* Patients affiliated with or beneficiaries of a social security or similar scheme (CMU).\n\nExclusion Criteria :\n\n* Parents who do not understand French.\n* Inability to set up monitoring equipment (neurosurgery preventing access to electrode placement sites).\n* Corrected age \\\u003C 37 weeks of gestation (GA) for preterm infants.","24 Months",{"count":89,"type":23},120,"OBSERVATIONAL","The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques.\n\nThis project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.",[29],[94,95,96],"Quantitative neuromonitoring","Pediatric and neonatal critical care","Neonatal encephalopathy","2026-03-06",{"date":99,"type":44},"2026-03-10",{"date":101,"type":44},"2025-09-16",{"date":103,"type":23},"2027-09-16",{"name":105,"class":51},"Nantes University Hospital",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":128,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":5},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413","NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","0 Hours","48 Hours",{"count":117,"type":23},1444,[119],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[122,123,124,125,29,126,127],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Breastfeeding","Mental Health Issue",[129,130],"Pasteurised donor human milk","Donor breastmilk","2026-01-29",{"date":133,"type":44},"2026-02-02",{"date":135,"type":44},"2025-12-04",{"date":137,"type":23},"2028-12",{"name":139,"class":51},"The University of Queensland"]