[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415109":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":28,"centralContacts":45,"locations":52,"responsibleParty":168,"collaborators":28,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":28,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":28,"overallStatus":55,"whyStopped":28,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"IBAIP Group","EXPERIMENTAL","Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).",[13,14,15,16],"Other: IBAIP : Infant Behaviour Assessment and Intervention Program","Other: Ages and Stages Questionnaire (ASQ)","Other: Parenting Stress Index (PSI)","Other: Bayley Scales of Infant and Toddler Development (BSID-IV)",{"label":18,"type":19,"description":20,"interventionNames":21},"Control group","ACTIVE_COMPARATOR","Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and \u002F or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up",[22,14,15,16],"Other: Standard Support",[24,29,33,37,41],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"IBAIP : Infant Behaviour Assessment and Intervention Program","The IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Standard Support","One medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and \u002F or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays",[18],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Ages and Stages Questionnaire (ASQ)","Global development screening tool",[18,9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Parenting Stress Index (PSI)","Index used to detect difficulties sufficiently significant that they might require psychosocial intervention",[18,9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"Bayley Scales of Infant and Toddler Development (BSID-IV)","This test was designed to measure the development of infants \u002F young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.",[18,9],[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Jean-Michel ROUE, PhD","CONTACT","2.98.22.36.67","+33","jean-michel.roue@chu-brest.fr",[53,70,83,96,110,123,133,141,154],{"facility":54,"status":55,"city":56,"state":28,"zip":28,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"CHU Angers","RECRUITING","Angers","France","FR",{"type":60,"coordinates":61},"Point",[62,63],-0.55202,47.47156,{"lat":63,"lon":62},[66],{"name":67,"role":48,"phone":68,"phoneExt":50,"email":69},"Bertrand LEBOUCHER","2.41.35.44.07","BeLeboucher@chu-angers.fr",{"facility":71,"status":55,"city":72,"state":28,"zip":28,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"CHU Besançon","Besançon",{"type":60,"coordinates":74},[75,76],6.01815,47.24878,{"lat":76,"lon":75},[79],{"name":80,"role":48,"phone":81,"phoneExt":50,"email":82},"Emma BECUWE-GOSSELIN","3.81.21.40.83","ebecuwe@chu-besancon.fr",{"facility":84,"status":55,"city":85,"state":28,"zip":86,"country":57,"countryCode":58,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"CHU Brest","Brest","29200",{"type":60,"coordinates":88},[89,90],-4.48628,48.39029,{"lat":90,"lon":89},[93,95],{"name":94,"role":48,"phone":28,"phoneExt":28,"email":28},"Jean-Michel ROUE",{"name":28,"role":48,"phone":28,"phoneExt":28,"email":51},{"facility":97,"status":55,"city":98,"state":28,"zip":99,"country":57,"countryCode":58,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"CHU Caen","Caen","14033",{"type":60,"coordinates":101},[102,103],-0.35912,49.18585,{"lat":103,"lon":102},[106],{"name":107,"role":48,"phone":108,"phoneExt":50,"email":109},"Valérie DATIN-DORRIERE, PhD","2.31.27.25.64","datindorriere-v@chu-caen.fr",{"facility":111,"status":55,"city":112,"state":28,"zip":28,"country":57,"countryCode":58,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"CHU Grenoble","Grenoble",{"type":60,"coordinates":114},[115,116],5.71479,45.17869,{"lat":116,"lon":115},[119],{"name":120,"role":48,"phone":121,"phoneExt":28,"email":122},"Blandine REBEILLE-BORGELLA","+33 4 76 76 55 77","brebeilleborgella@chu-grenoble.fr",{"facility":124,"status":125,"city":126,"state":28,"zip":127,"country":57,"countryCode":58,"cosmosGeoPoint":128,"geoPoint":132,"contacts":28},"CHU Nantes","WITHDRAWN","Nantes","44000",{"type":60,"coordinates":129},[130,131],-1.55336,47.21725,{"lat":131,"lon":130},{"facility":134,"status":125,"city":135,"state":28,"zip":28,"country":57,"countryCode":58,"cosmosGeoPoint":136,"geoPoint":140,"contacts":28},"CHU Rennes","Rennes",{"type":60,"coordinates":137},[138,139],-1.67431,48.11109,{"lat":139,"lon":138},{"facility":142,"status":55,"city":143,"state":28,"zip":28,"country":57,"countryCode":58,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"CHRU Strasbourg","Strasbourg",{"type":60,"coordinates":145},[146,147],7.74553,48.58392,{"lat":147,"lon":146},[150],{"name":151,"role":48,"phone":152,"phoneExt":50,"email":153},"Pierre KUHN","3.88.12.77.76","Pierre.Kuhn@chru-strasbourg.fr",{"facility":155,"status":55,"city":156,"state":28,"zip":157,"country":57,"countryCode":58,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"CHU Tours","Tours","37000",{"type":60,"coordinates":159},[160,161],0.70398,47.39484,{"lat":161,"lon":160},[164],{"name":165,"role":48,"phone":166,"phoneExt":50,"email":167},"Delphine MITANCHEZ","2.47.47.92.48","delphine.mitanchez@univ-tours.fr",{"type":169,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100415109","effect-of-the-ibaip-in-preterm-infants-neurodevelopment-100415109",false,"NCT04685356","Effect of the IBAIP in Preterm Infants Neurodevelopment","Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age","IBAIP","Inclusion Criteria :\n\n* Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.\n* Written informed consent of at least one of the parents \u002F legal guardian or 2 parents \u002F legal guardians depending on the family context\n* Normal neurological examination between 36 and 41 weeks of corrected age\n\nExclusion Criteria:\n\n* Intraventricular hemorrhage (III or IV), periventricular leukomalacia\n* Brain MRI abnormalities performed after 36 weeks of corrected age\n* Life-threatening pathology\n* Severe congenital abnomality\n* Severe maternal pathology (physical and \u002F or mental)\n* Parents whose native language is not French\n* Participation in another interventional study on the management of post-hospital neurodevelopment disorders","ALL","25 Weeks","32 Weeks",{"count":182,"type":183},240,"ESTIMATED","INTERVENTIONAL",[186],"NA","Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.\n\nThese neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.\n\nPost-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.\n\nEarly interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.\n\nThe IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.",[189],"Premature Birth","2026-06-24",{"date":192,"type":193},"2026-06-26","ACTUAL",{"date":195,"type":193},"2022-11-08",{"date":197,"type":183},"2028-01-08",{"name":5,"class":6},9]