[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638769":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":58,"slug":26,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","PLACEBO_COMPARATOR","Standard obstetric care will be at the discretion of the delivery provider.",[13],"Other: Standard obstetric care at discretion of delivery provider",{"label":15,"type":16,"description":17,"interventionNames":18},"Room Temperature Lactated Ringer Amnioinfusion","EXPERIMENTAL","Standardized room temperature amnioinfusion consisting of a 500 mL bolus of (24°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL\u002Fhour. Infusion continues until 1L is infused or delivery occurs.",[19],"Device: Intrauterine Pressure Catheter",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Intrauterine Pressure Catheter","Standardized room temperature amnioinfusion consisting of a 500mL bolus of (24°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL\u002Fhour. Infusion continues until 1L is infused or delivery occurs.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard obstetric care at discretion of delivery provider","Route obstetric care at the discretion of delivery provider.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Brock E Polnaszek, MD,MPH","CONTACT","(414)-805-6600","bpolnaszek@mcw.edu",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Froedtert Hospital and Medical College of Wisconsin Birth Center","Milwaukee","Wisconsin","53045","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.90647,43.0389,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":33,"role":54,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Brock E. Polnaszek, MD MPH","Assistant Professor and Primary Investigator MD, MPH","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":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75,76,77],"Chorioamnionitis Affecting Fetus or Newborn","Amnioinfusion","Neonatal Brain Injury",[76,79,80,81,82,83,84,85],"Neonatal morbidity","Maternal morbidity","Umbilical cord gas","Healthcare Utilization","Neonatal hypoxic brain injury","Chorioamnionitis","Neonatal brain biomarkers","NOT_YET_RECRUITING","2026-05-27",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":69},"2026-07-01",{"date":94,"type":69},"2027-12",{"name":5,"class":6},1]