[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408479":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":67,"collaborators":69,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":23,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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",[35,53],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Nemours Children's Hospital","RECRUITING","Orlando","Florida","32827","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.37924,28.53834,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":23,"email":33},"Sreekanth Viswanathan","407-697-7603",{"facility":54,"status":37,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Emory University","Atlanta","Georgia","30329",{"type":44,"coordinates":59},[60,61],-84.38798,33.749,{"lat":61,"lon":60},[64],{"name":65,"role":31,"phone":23,"phoneExt":23,"email":66},"Kera McNelis, MD","kmmcnel@emory.edu",{"type":27,"investigatorFullName":51,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Attending Neonatologist, Professor of Pediatrics",[70],{"name":54,"class":6},"100408479","role-of-body-composition-in-large-for-gestational-age-infants-lga-with-oral-feeding-difficulty-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":83,"type":84},40,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91,92],"Body Composition","Feeding; Difficult, Newborn","Nutrition Disorder, Infant","2026-05-22",{"date":95,"type":96},"2026-05-27","ACTUAL",{"date":98,"type":96},"2024-09-26",{"date":100,"type":84},"2027-12-31",{"name":5,"class":6},2]