[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639413":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":60,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Outborn Infants",null,"Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care.",[13],"Other: Usual Care",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Usual Care","Children will be followed using each participating center's usual practices. Parental experiences of hospitalization, parental mental health and health-related quality of life since discharge will be assessed by telephone at 6, 12, 18, and 24 months of corrected age.",[9],[20],{"name":21,"affiliation":22,"role":23},"Peter JONES, MB BChir PhD","SAMU du Val de l'Oise","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","06 12 34 76 82","+33","peter.jones@aphp.fr",[31],{"facility":32,"status":10,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"SAMU de Pontoise, Hopital Novo","Pontoise","95300","France","FR",{"type":38,"coordinates":39},"Point",[40,41],2.1,49.05,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":28,"email":47},"Guillaume POIRIE, MD","06 30 61 08 13","guillaume.poirie@ght-novo.fr",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100639413","antenatal-vs-postnatal-transport-team-positioning-in-extremely-preterm-outborn-infants-100639413",false,"NCT07580859","Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants","A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol","OutbornTRANSF","Eligible for inclusion are infants for whom an antenatal call to the emergency medical service (SAMU) was initiated due to prematurity (imminent delivery and infant alive at the time of the call) and who:\n\n* Were born outside a level 3 maternity hospital (outborn birth) in mainland France\n* Have a gestational age at birth between of 23+0 - 28+6\n* Have parents who speak and understand French (required for telephone follow-up) To assess parent-related outcomes, parents will also be included in the study if their infant is eligible and if they have not objected to participation.\n\nInfants will not be included if one or both parents are unable to speak and understand French, if at least one of the parents is opposed to inclusion, if they had lethal congenital malformations or if they were born outside hospital (accidental premature home births).","ALL","0 Days","28 Months",{"count":62,"type":63},627,"ESTIMATED","OBSERVATIONAL","The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).\n\nThis project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.\n\nStudy will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.\n\nIf parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.\n\nThrough a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.",[67,68,69],"Prematurity Complications","Neurodevelopment Outcome","Prematurity",[69,71,72,73,74,75],"Outborn","Transport","Mortality","Cohort study","Neurodevelopment","NOT_YET_RECRUITING","2026-05-26",{"date":79,"type":80},"2026-05-28","ACTUAL",{"date":82,"type":63},"2026-06",{"date":84,"type":63},"2030-09",{"name":5,"class":6},1]