[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100638769","amnioinfusion-for-chorioamnionitis-targeting-neonatal-brain-injury-biomarkers-100638769",false,"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","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Chorioamnionitis Affecting Fetus or Newborn","Amnioinfusion","Neonatal Brain Injury",[28,31,32,33,34,35,36,37],"Neonatal morbidity","Maternal morbidity","Umbilical cord gas","Healthcare Utilization","Neonatal hypoxic brain injury","Chorioamnionitis","Neonatal brain biomarkers","NOT_YET_RECRUITING","2026-05-27",{"date":41,"type":42},"2026-05-29","ACTUAL",{"date":44,"type":21},"2026-07-01",{"date":46,"type":21},"2027-12",{"name":48,"class":49},"Medical College of Wisconsin","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":75,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":50},"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":60,"type":21},320,[24],"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.",[64,65,66,67,68,29,69,70,71,72,73,28,74],"Neonatal Respiratory Distress Related Conditions","Meconium","Perinatal Morbidity","Neonatal Acidosis","Cord Blood","Maternal Morbidity","Mechanical Ventilation","CPAP","Surfactant","Perinatal Death","NICU Admission",[28,65,31,76,69,77,78,34],"Developmental Screening","Neonatal respiratory morbidity","Umbilical cord gas and biomarkers","RECRUITING","2026-05-15",{"date":82,"type":42},"2026-05-19",{"date":80,"type":42},{"date":85,"type":21},"2030-04-15",{"name":48,"class":49}]