[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408479":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":66,"collaborators":68,"id":70,"slug":23,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":23,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":23,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Nemours Children's Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FFM-indexed feeding","ACTIVE_COMPARATOR","In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL\u002Fkg (FFM)\u002Fday without increasing the milk calorie density or changing the type of formula milk for 2 weeks in the intervention group",[13],"Other: Dietary intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard feeding","The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL\u002Fkg\u002Fday during the 2-week study period",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Dietary intervention","energy-restricted diet appropriate for resting metabolic rate using FFM as proxy",[9,15],null,[25],{"name":26,"affiliation":5,"role":27},"Sreekanth Viswanathan, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Sreekanth Viswanathan, MD,MS","CONTACT","4076977603","sreekanth.viswanathan@nemours.org",[35,52],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Nemours Children's Hospital","RECRUITING","Orlando","Florida","32827","United States",{"type":43,"coordinates":44},"Point",[45,46],-81.37924,28.53834,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":51,"phoneExt":23,"email":33},"Sreekanth Viswanathan","407-697-7603",{"facility":53,"status":37,"city":54,"state":55,"zip":56,"country":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Emory University","Atlanta","Georgia","30329",{"type":43,"coordinates":58},[59,60],-84.38798,33.749,{"lat":60,"lon":59},[63],{"name":64,"role":31,"phone":23,"phoneExt":23,"email":65},"Kera McNelis, MD","kmmcnel@emory.edu",{"type":27,"investigatorFullName":50,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Attending Neonatologist, Professor of Pediatrics",[69],{"name":53,"class":6},"100408479",false,"NCT04599010","Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty","Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.","Inclusion Criteria:\n\n* LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \\> +1.0 in body composition measurement\n\nExclusion Criteria:\n\n* Infants on any respiratory support, Infants on enteral feeding duration \\> 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes\u002Fanomalies",true,"ALL","1 Week","10 Weeks",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"NA","Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.",[88,89,90],"Body Composition","Feeding; Difficult, Newborn","Nutrition Disorder, Infant","2026-05-22",{"date":93,"type":94},"2026-05-27","ACTUAL",{"date":96,"type":94},"2024-09-26",{"date":98,"type":82},"2027-12-31",{"name":5,"class":6},2]