[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395488":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate umbilical cord clamping","ACTIVE_COMPARATOR","This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines (\"Programme National de Soins\").The resuscitation maneuvers are started after the umbilical cord is clamped.",[13],"Procedure: Immediate umbilical cord clamping",{"label":15,"type":16,"description":17,"interventionNames":18},"Intact cord resuscitation","EXPERIMENTAL","This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines (\"Programme National de Soins\") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child.",[19],"Procedure: intact cord resuscitation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French \"Programme National de Soins\".\n\nAfter cardiorespiratory stabilization (i.e. heart rate\\>120\u002Fmin, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping).",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"intact cord resuscitation","The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter\u002Fblender, ventilatory support, and monitoring system. Its height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate\\>120\u002Fmin, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).",[15],[31],{"name":32,"affiliation":5,"role":33},"Laurent Storme, MD,PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","03 20 44 61 99","+33","laurent.storme@chru-lille.fr",[41,53,65],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"Chu Amiens Picardie","RECRUITING","Amiens","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3,49.9,{"lat":51,"lon":50},{"facility":54,"status":43,"city":55,"state":25,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Hop Jeanne de Flandre Chu Lille","Lille","59037",{"type":48,"coordinates":58},[59,60],3.05512,50.63391,{"lat":60,"lon":59},[63],{"name":25,"role":36,"phone":64,"phoneExt":25,"email":25},"0320445962",{"facility":66,"status":43,"city":67,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":25},"Chu de Nantes -","Nantes",{"type":48,"coordinates":69},[70,71],-1.55336,47.21725,{"lat":71,"lon":70},{"type":74,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[76],{"name":77,"class":78},"Ministry of Health, France","OTHER_GOV","100395488","intact-cord-resuscitation-in-cdh-100395488",false,"NCT04429750","Intact Cord Resuscitation in CDH","Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)","CHIC","Inclusion Criteria:\n\n* Antenatal diagnosis of CDH\n* No severe additional malformation or chromosomal diseases\n* Full term (\\>36 weeks gestational age)\n* No inclusion in another antenatal trial\n* Written informed consents from the parents\n\nExclusion Criteria:\n\n* Preterm birth less than 37 weeks gestational age\n* Other severe malformation(s) or chromosomal diseases\n* Twin\n* Parents who may have French language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. If included in the study, regarding their French understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist","ALL","36 Weeks","37 Weeks",{"count":91,"type":92},180,"ESTIMATED","INTERVENTIONAL",[95],"NA","Isolated CDH is a rare disease (1\u002F3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad.\n\nSeveral studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH.\n\nThis multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.",[98,99],"Rare Diseases","Congenital Diaphragmatic Hernia",[101,102,103,104],"Congenital diaphragmatic hernia","resuscitation","delayed cord clamping","newborn","2026-05-19",{"date":107,"type":108},"2026-05-20","ACTUAL",{"date":110,"type":108},"2020-10-08",{"date":112,"type":92},"2026-10",{"name":5,"class":6},3]