[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-brain-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,87,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100651679","eeg-based-decision-support-algorithm-for-hypoxic-ischemic-encephalopathy-in-term-newborns-100651679",false,"NCT07764315","EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns","Retrospective Multicenter Validation of a Conventional EEG-Based Decision-Support Algorithm to Discriminate Mild Versus Moderate\u002FSevere Hypoxic-Ischemic Encephalopathy in Term Newborns (Newborn Neuro Digital Project)","COOLDECIDE","Inclusion Criteria:\n\n* No parental opposition to the use of the child's medical data within 1 month of the mailed information notice\n* Gestational age ≥ 36 weeks of amenorrhea\n* Birth weight ≥ 1800 g\n* Born in a context of perinatal asphyxia (any cause) leading to suspected HIE, with EITHER biological signs of metabolic acidosis (pH ≤ 7 or base deficit ≥ 16 mmol\u002FL or lactate ≥ 11 mmol\u002FL within the first hour of life, any blood sample) OR a history of asphyxia with Apgar ≤ 5 at 10 minutes or need for ventilatory resuscitation continued at 10 minutes of life\n* Non-compressed conventional EEG (EEGc) recorded before the 6th hour of life\n* EEG including the signal of active electrodes Fp1, Fp2, T3 and T4\n\nExclusion Criteria:\n\n* Participation in a therapeutic biomedical research liable to modify the EEG tracing\n* Fewer than 20 minutes of artifact-free EEG recording\n* Signal from active electrodes Fp1, Fp2, T3 and T4 not exploitable","ALL","0 Days","1 Day",{"count":21,"type":22},310,"ESTIMATED","OBSERVATIONAL","This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). The algorithm reads the raw (non-compressed) EEG signal. Its output is compared with the reference reading of the full conventional EEG made by a panel of pediatric neurophysiologists together with the baby's clinical information. The study uses only medical data that already exists and asks nothing of the babies or their families.",[26,27,28],"Hypoxic-Ischemic Encephalopathy","Perinatal Asphyxia","Neonatal Brain Injury",[30,31,32,33,34,35],"conventional EEG","therapeutic hypothermia","decision-support software","term newborn","diagnostic accuracy","medical device software","NOT_YET_RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-13","ACTUAL",{"date":42,"type":22},"2026-09-16",{"date":44,"type":22},"2027-02-16",{"name":46,"class":47},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100646821","phase-1-neonatal-white-matter-injury-trial-wrap-100646821","NCT07688746","Neonatal White Matter Injury Trial (WRAP)","An Open-label, Dose-escalation, Phase I\u002FIb Clinical Trial to Assess the Safety and Pharmacokinetics of Clemastine in Preterm Neonates With White Matter Injury (WRAP)","WRAP","Inclusion Criteria:\n\n1. Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP).\n2. Current age of between 35-41 weeks PMA.\n3. Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria:\n\n   * Brain MRI with Grade Ib WMI or higher based on the Martinez-Biarge et al 2016 criteria.\n   * cUS with Grade 3 or higher white matter abnormalities based on Miller et al 2003 criteria.\n4. Currently hospitalized in a participating intensive care nursery.\n\nExclusion Criteria:\n\n1. Known or suspected metabolic or chromosomal disorder or major congenital anomalies\n2. Major intracranial hemorrhage within the last 1 week or intracranial hemorrhage of any age that is not controlled or continuing to cause significant mass effect or midline shift.\n3. History of cardiac arrhythmia or current ongoing tachycardia with baseline heart rate \\>10% age expected norms.\n4. Hypotension requiring ongoing vasopressor or inotropic support.\n5. Not able to receive enteral medications.\n6. Clinically significant sedation due to critical illness or medications.\n7. Concomitant use of any other putative neuroprotective or myelination promoting therapy as determined by the investigator.\n8. Serum creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \\>2x the upper limit of normal for age.\n9. Family history of epilepsy due to a confirmed or suspected genetic cause.\n10. History of confirmed seizure activity.\n11. If ≥36 weeks postmenstrual age, required respiratory support greater than 2L\u002Fmin, noninvasive positive airway pressure, or mechanical ventilation upon reaching 36 weeks postmenstrual age due to diagnosis of moderate or severe BPD.\n12. If less than 36 weeks postmenstrual age, currently requiring respiratory support greater than 2L\u002Fmin, noninvasive positive airway pressure, or mechanical ventilation, unless respiratory support is being given to promote lung development and not due to clinical need.\n13. Major medical conditions, laboratory abnormalities, or concurrent treatments that, in opinion of the investigator, may affect interpretation of study results or patient safety.","3 Weeks","20 Weeks",{"count":59,"type":22},24,"INTERVENTIONAL",[62],"PHASE1","The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body.",[65,66,28,67,68],"White Matter Injury","Brain Injury, Fetus and Neonate","Periventricular Leukomalacia","Periventricular White Matter Abnormalities",[70,71,72,73,74,75,76],"infant","neonate","brain injury","clemastine","white matter injury","prematurity","neuroprotection","RECRUITING","2026-07-26",{"date":80,"type":40},"2026-07-28",{"date":78,"type":40},{"date":83,"type":22},"2031-07-01",{"name":85,"class":47},"Bridget LaMonica Ostrem, M.D., Ph.D.",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":60,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":86},"100638769","amnioinfusion-for-chorioamnionitis-targeting-neonatal-brain-injury-biomarkers-100638769","NCT07610642","Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers","The AMNIO-BRAIN Trial: A Randomized Trial of Amnioinfusion for Chorioamnionitis Targeting Neonatal Brain Injury Biomarkers","AMNIO-BRAIN","Inclusion Criteria:\n\n* Maternal age ≥18 years\n* Singleton gestation\n* Gestational age ≥36 weeks\n* Labor at time of enrollment\n* Clinical chorioamnionitis or intra-amniotic infection defined according to ACOG criteria, including: Maternal temperature ≥38.0°C At least one associated clinical finding, including:\n* 1\\. Maternal leukocytosis\n* 2\\. Purulent cervical drainage\n* 3\\. Fetal tachycardia\n* Cervical dilation sufficient for intrauterine pressure catheter placement\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Known major fetal anomaly\n* Contraindication to vaginal delivery\n* Placenta previa\n* Category III fetal heart tracing requiring immediate delivery\n* Non-English-speaking","18 Years",{"count":97,"type":22},80,[99],"NA","The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain.\n\nSome newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the brain does not get enough oxygen or blood flow. This can lead to serious health problems, including developmental delays and lifelong disabilities. While there is a cooling treatment after birth that can help, it starts only after delivery and may come too late to prevent the earliest stages of injury.\n\nResearch suggests that some brain injury may actually begin during labor, especially when there is an infection in the uterus called chorioamnionitis. This infection can cause inflammation and fever in the mother, which may increase stress on the baby and affect the baby's brain.\n\nThis study is testing whether a commonly used labor procedure called amnioinfusion can help. Amnioinfusion involves placing fluid similar to your biologic amniotic fluid into the uterus during labor. It is already used safely in many deliveries for other reasons. In prior research, this treatment slightly lowered the temperature inside the uterus and improved signs that the baby was no longer under stress.\n\nIn this study, 80 pregnant subjects with chorioamnionitis will be randomly assigned to receive amnioinfusion during labor or receive standard care without amnioinfusion. All patients will continue to receive normal treatment for infection.\n\nAfter delivery, researchers will collect a small sample of blood from the umbilical cord. This blood will be tested for markers that can show whether the baby may have experienced stress or injury to the brain.",[102,103,28],"Chorioamnionitis Affecting Fetus or Newborn","Amnioinfusion",[103,105,106,107,108,109,110,111],"Neonatal morbidity","Maternal morbidity","Umbilical cord gas","Healthcare Utilization","Neonatal hypoxic brain injury","Chorioamnionitis","Neonatal brain biomarkers","2026-05-27",{"date":114,"type":40},"2026-05-29",{"date":116,"type":22},"2026-07-01",{"date":118,"type":22},"2027-12",{"name":120,"class":47},"Medical College of Wisconsin",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":60,"phases":131,"briefSummary":132,"conditions":133,"keywords":145,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":86},"100614048","amnioinfusions-protective-effects-on-respiratory-and-longitudinal-pediatric-outcomes-after-intrapartum-thick-meconium-exposure-100614048","NCT07274527","Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","PEARL","Inclusion Criteria:\n\n* Maternal age greater than or equal to 18 years old\n* Singleton pregnancy\n* Gestational age of greater than or equal to 36 weeks 0 days gestation\n* Cephalic presentation\n* Cercial dilation between 2-10 centimeters\n* Meconium\n\nExclusion Criteria:\n\n* Major fetal anomaly\n* Multiple gestation\n* Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing\n* Contraindication to internal monitors\n* Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent",{"count":130,"type":22},320,[99],"Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension.\n\nAlthough amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly thick.\n\nThe PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop thick meconium-stained amniotic fluid, confirmed using a simple, objective measurement (\"meconium-crit\"). Participants will be randomly assigned to receive either:\n\nWarm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.\n\nThe main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice.\n\nBy using a clear definition of thick meconium, a warm LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.",[134,135,136,137,138,28,139,140,141,142,143,103,144],"Neonatal Respiratory Distress Related Conditions","Meconium","Perinatal Morbidity","Neonatal Acidosis","Cord Blood","Maternal Morbidity","Mechanical Ventilation","CPAP","Surfactant","Perinatal Death","NICU Admission",[103,135,105,146,139,147,148,108],"Developmental Screening","Neonatal respiratory morbidity","Umbilical cord gas and biomarkers","2026-05-15",{"date":151,"type":40},"2026-05-19",{"date":149,"type":40},{"date":154,"type":22},"2030-04-15",{"name":120,"class":47}]