[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521071":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":128,"collaborators":10,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":10,"studyType":144,"phases":10,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"patients received the investigational medicinal product acetaminophen in their first 5 days of life",null,"This group of patients received the investigational product in their first 5 days of life during the Treocapa trial",[13],"Other: 2 year follow-up of neurodevelopment using a parental questionnaire",{"label":15,"type":10,"description":16,"interventionNames":17},"patients received the placebo (NaCl) in their first 5 days of life","This group of patients received the placebo in their first 5 days of life during the Treocapa trial",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","2 year follow-up of neurodevelopment using a parental questionnaire","A parental questionnaire, using the PARCA-R instrument, is given to measure cognitive outcome at 2 years of corrected age for children included in the Treocapa Trial",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Jennifer Zeitlin","STUDY_DIRECTOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Gilles Cambonie, MD\u002FPHD","CONTACT","+33467336609","g-cambonie@chu-montpellier.fr",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Andrei Morgan, FRCPCH, MSc, PhD","+33171722987","andrei.morgan@inserm.fr",[39,54,65,76,87,98,106,117],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"CHU d'Angers","RECRUITING","Angers","France","FR",{"type":46,"coordinates":47},"Point",[48,49],-0.55202,47.47156,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":10,"phoneExt":10,"email":10},"Marion Plourde",{"facility":55,"status":41,"city":56,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Hôpital Femme Mère Enfant","Bron",{"type":46,"coordinates":58},[59,60],4.91303,45.73865,{"lat":60,"lon":59},[63],{"name":64,"role":31,"phone":10,"phoneExt":10,"email":10},"Kim An Nguyen",{"facility":66,"status":41,"city":67,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"CHU de Montpellier","Montpellier",{"type":46,"coordinates":69},[70,71],3.87635,43.61093,{"lat":71,"lon":70},[74],{"name":75,"role":31,"phone":10,"phoneExt":10,"email":10},"Gilles Cambonie",{"facility":77,"status":41,"city":78,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU de Nantes","Nantes",{"type":46,"coordinates":80},[81,82],-1.55336,47.21725,{"lat":82,"lon":81},[85],{"name":86,"role":31,"phone":10,"phoneExt":10,"email":10},"Cyril Flamant",{"facility":88,"status":41,"city":89,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Cochin - APHP","Paris",{"type":46,"coordinates":91},[92,93],2.3488,48.85341,{"lat":93,"lon":92},[96],{"name":97,"role":31,"phone":10,"phoneExt":10,"email":10},"Juliana Patkai",{"facility":99,"status":41,"city":89,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Hopital Robert Debré",{"type":46,"coordinates":101},[92,93],{"lat":93,"lon":92},[104],{"name":105,"role":31,"phone":10,"phoneExt":10,"email":10},"Valérie Biran",{"facility":107,"status":41,"city":108,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU de Strasbourg","Strasbourg",{"type":46,"coordinates":110},[111,112],7.74553,48.58392,{"lat":112,"lon":111},[115],{"name":116,"role":31,"phone":10,"phoneExt":10,"email":10},"Pierre Kuhn",{"facility":118,"status":41,"city":119,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CHU de Tours","Tours",{"type":46,"coordinates":121},[122,123],0.70398,47.39484,{"lat":123,"lon":122},[126],{"name":127,"role":31,"phone":10,"phoneExt":10,"email":10},"Antoine Bouissou",{"type":129,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100521071","long-term-follow-up-of-the-treocapa-study-treocapa-lt-100521071",false,"NCT06064825","Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)","Long Term Follow-up of the TREOCAPA (Prophylactic TREatment Of the duCtus Arteriosus in Preterm Infants by Acetaminophen) Study (TREOCAPA-LT)","TREOCAPA-LT","Inclusion Criteria:\n\n* were included in the TREOCAPA phase III RCT in participating centres\n* are aged between 23.5 and 27.5 months corrected age during the study period\n\nExclusion Criteria:\n\n* if the local investigator does not have up-to-date contact information allowing contact with parents\n* if the child's vital status cannot be ascertained\n* if the child is nearing the end of his life or experiencing a severe medical event as assessed by the local investigator\n* if the child has become subject to a legal protection measure preventing their ongoing participation in clinical research\n* if either parent or guardian opts out of participating\n* language barrier","ALL","23 Months","27 Months",{"count":142,"type":143},500,"ESTIMATED","OBSERVATIONAL","The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus arteriosus (PDA). In these patients, PDA has been associated with increased mortality and morbidity in the neonatal period, and neonatal morbidities may in turn be associated with later deficits in cognitive functioning. PDA treatment with COX inhibitors, as ibuprofen or indomethacin, aiming at closing the PDA have been associated with numerous adverse effects and failed to demonstrate significant clinical benefits. Early treatment of PDA with paracetamol (acetaminophen ) has been proposed as an alternative to COX inhibitors. The ongoing pan-European TREOCAPA phase III study (NCT04459117) is a multicentre, double-blind, randomised, placebo-controlled superiority trial that assesses prophylactic use of paracetamol to improve survival without severe neonatal morbidity until discharge from hospital in infants of 23-28 weeks of gestational age. As long-term follow-up was not planned by the TREOCAPA protocol, TREOCAPA-LT study will use an existing European research infrastructure, the RECAP Preterm platform (https:\u002F\u002Frecap-preterm.eu\u002F), to follow-up the patients enrolled in the TREOCAPA trial using a parent-report questionnaire at 2 years of corrected age.\n\nThe TREOCAPA-LT primary hypothesis is that there will be improved cognitive outcome at 2 years of corrected age in children born at less than 29 weeks of gestational age who were treated with paracetamol during the first 5 days of life in the TREOCAPA phase III trial.",[147],"Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity",[149,150,151,152],"Premature infants","persistent ductus arteriosus","paracetamol\u002Facetaminophen","long term outcome","2026-04-13",{"date":155,"type":156},"2026-04-16","ACTUAL",{"date":158,"type":156},"2023-12-12",{"date":160,"type":143},"2027-06",{"name":5,"class":6},8]