[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543079":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":12,"locations":24,"responsibleParty":46,"collaborators":12,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":12,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":27,"whyStopped":12,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No abdominal massage group","NO_INTERVENTION","During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Abdominal massage group","EXPERIMENTAL","At least 10 abdominal massages will be performed on preterms, by a physiotherapist trained in this technique over a period of 14 days, at the rate of one massage per day.",[18],"Other: Abdominal massage",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Abdominal massage","An abdominal massage for premature babies lasts 10 minutes. Our abdominal massage techniques is described in our protocole and will be adapted according to the term of the child.",[14],[25],{"facility":26,"status":27,"city":28,"state":12,"zip":12,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"CHU clermont-ferrand","RECRUITING","Clermont-Ferrand","France","FR",{"type":32,"coordinates":33},"Point",[34,35],3.08682,45.77969,{"lat":35,"lon":34},[38,43],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},"Lise LACLAUTRE","CONTACT","334.73.754.963","llaclautre_perrier@chu-clermontferrand.fr",{"name":44,"role":45,"phone":12,"phoneExt":12,"email":12},"Marie COLNE","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100543079","impact-assessment-of-abdominal-massage-on-feeding-tolerance-of-preterms-100543079",false,"NCT06351202","Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms","Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial","PREMABDO","Inclusion Criteria:\n\n* Newborn, premature, less than 34 Weeks of Amennorhea\n* at least 3 days of life\n* hospitalized in neonatal intensive care units\n* with feeding intolerance demonstrated by an ECAP (Clinical Abdominal Assessement scale for preterms) score equal to or greater than 4\u002F20\n* whose holders of parental authority are able to give free and informed consent to participate in this study.\n\nExclusion Criteria:\n\n* premature newborns with a congenital pathology such as malformation, genetic or chromosomal abnormality\n* newborns whose holders of parental authority are protected by law (under guardianship, curatorship, placed under judicial safeguard) or aged under 18\n* rejection of participation by parents\n* newborns with a contraindication to abdominal massage (fever, major hemodynamic instability)","ALL","3 Days","60 Days",{"count":60,"type":61},120,"ESTIMATED","INTERVENTIONAL",[64],"NA","Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.\n\nAt the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.\n\nIn this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.\n\nThe hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.\n\nThe aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days.",[67,68],"Preterm Birth Complication","Digestive System Disease",[70,71],"physiotherapy","abdominal massage","2024-05-21",{"date":74,"type":75},"2024-05-22","ACTUAL",{"date":77,"type":75},"2024-05-16",{"date":79,"type":61},"2026-06",{"name":5,"class":6},1]