[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chorioamnionitis-affecting-fetus-or-newborn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chorioamnionitis-affecting-fetus-or-newborn":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,83],{"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":59,"sex":60,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":50},"100609203","il-6-and-lactates-in-cord-blood-and-neonatal-outcomes-100609203","NCT07211503","IL-6 and Lactates in Cord Blood and Neonatal Outcomes","Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern","ECCO-IL6","Inclusion Criteria:\n\nSOFI case group:\n\n* Women with gestational age \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation\n* Age ≥18 years\n* Presence of CTG characteristics associated with fetal inflammation\u002Finfection (fetal heart rate (fetal heart rate (FHR) \\>150 bpm with gestational age \\>40 weeks or a 10% increase in FHR, absence of cycling, fetal tachycardia \\>=160 bpm, variability \\\u003C5 bpm)\n* Signed informed consent form by the patient.\n\nNEFI control group:\n\n* Women with gestation \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation.\n* Age ≥18 years.\n* Patients with a CTG tracing that does not show features associated with fetal inflammation\u002Finfection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm).\n* Patient signed informed consent form.\n\nExclusion Criteria:\n\n* Failure to sign informed consent\n* Intrauterine fetal death\n* Congenital fetal and\u002For chromosomal abnormalities\n* Maternal cardiac abnormalities and\u002For cardiac therapy and\u002For therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin)\n* Twin or multiple pregnancy",true,"FEMALE",{"count":62,"type":21},160,"OBSERVATIONAL","The goal of this observational study or clinical trial is to evaluate interleukin-6 (IL-6) and lactate levels in maternal and cord blood to identify early signs of fetal inflammation or infection.\n\nTwo groups of women with full-term pregnancies will be compared: • Case group (SOFI): women with a cardiotocograph (CTG) pattern suspicious for fetal infection\u002Finflammation • Control group (NEFI): women with a normal cardiotocograph (CTG) pattern without signs of inflammation. The primary outcome is to evaluate whether IL-6 levels detected in the umbilical artery, alone or in combination with maternal IL-6 values, are associated with a cardiotocograph (CTG) pattern suggestive of fetal inflammation and\u002For a clinical picture suggestive of chorioamnionitis. Identifying a possible correlation between IL-6\u002Flactate levels and fetal inflammatory status could facilitate more timely treatment of at-risk infants in the future, contributing to the reduction of adverse outcomes both in the neonatal period and in the long-term.\n\nSecondary outcome are: -Comparison of fetal and maternal IL-6 levels between infants with a composite adverse outcome; - Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.",[66,67,36,27],"Fetal Infection","Fetal Inflammatory Response Syndrome",[69,70,71,72,73],"il6","chorioamnionitis","FIRS","lactates","labour","2025-09-30",{"date":76,"type":42},"2025-10-08",{"date":78,"type":21},"2025-10-01",{"date":80,"type":21},"2027-04-30",{"name":82,"class":49},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":59,"sex":60,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100604637","amniotic-fluid--the-preterm-gut-100604637","NCT07152106","Amniotic Fluid & the Preterm Gut","The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study","AMFIBIE","Inclusion Criteria:\n\n* Maternal age ≥16 years\n* Written informed consent\n* Successful collection of amniotic fluid\n\nExclusion Criteria:\n\n* Pregnancies complicated by fetal congenital and\u002For chromosomal abnormalities.\n* Insufficient proficiency of Dutch or English language","16 Years",{"count":93,"type":21},275,"Background:\n\nNecrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and\u002For fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.\n\nMethods:\n\nln this multicenter, prospective, cohort study, AF (\\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0\u002F7-27+6\u002F7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \\\u003C23+\u002F7 weeks), very early and moderate to late preterm (GA 28+0\u002F6-36+6\u002F7 weeks), and full-term pregnancies (GA 37+0\u002F7-41+6\u002F7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.\n\nDiscussion and expected results:\n\nAF profiles associated with CAM and\u002For FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.",[36,27,96,97,98,99,100,101],"Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Neonatal Sepsis, Late-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","Prematurity Complications","RECRUITING","2025-08-28",{"date":105,"type":42},"2025-09-03",{"date":107,"type":42},"2024-10-14",{"date":109,"type":21},"2027-10-14",{"name":111,"class":49},"Maxima Medical Center",2]