[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604637":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":20,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Maxima Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort",null,"Total cohort consists of: 1) study group - gestational age 24+0\u002F7-27+6\u002F7 weeks, 2) reference\u002Fcontrol group: \\\u003C24+0\u002F7 weeks and 28+0\u002F7-40+6\u002F7 weeks",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Mirjam M. van Weissenbruch","CONTACT","020 566 9111","m.vanweissenbruch@amsterdamumc.nl",{"name":19,"role":15,"phone":10,"phoneExt":10,"email":10},"Hendrik Niemarkt, dr",[21,35],{"facility":22,"status":23,"city":24,"state":10,"zip":10,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Amsterdam UMC","RECRUITING","Amsterdam","Netherlands","NL",{"type":28,"coordinates":29},"Point",[30,31],4.88969,52.37403,{"lat":31,"lon":30},[34],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"facility":36,"status":23,"city":37,"state":10,"zip":10,"country":25,"countryCode":26,"cosmosGeoPoint":38,"geoPoint":42,"contacts":43},"Máxima Medical Center","Veldhoven",{"type":28,"coordinates":39},[40,41],5.40278,51.41833,{"lat":41,"lon":40},[44],{"name":45,"role":15,"phone":46,"phoneExt":10,"email":47},"Hendrik Niemarkt","040 888 8000","hendrik.niemarkt@mmc.nl",{"type":49,"investigatorFullName":45,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100604637","amniotic-fluid--the-preterm-gut-100604637",false,"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",true,"FEMALE","16 Years",{"count":63,"type":64},275,"ESTIMATED","OBSERVATIONAL","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.",[68,69,70,71,72,73,74,75],"Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn","Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Neonatal Sepsis, Late-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","Prematurity Complications","2025-08-28",{"date":78,"type":79},"2025-09-03","ACTUAL",{"date":81,"type":79},"2024-10-14",{"date":83,"type":64},"2027-10-14",{"name":5,"class":6},2]