[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584790":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":136,"collaborators":139,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":28,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":122,"whyStopped":28,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Extended Trophic Feeding","ACTIVE_COMPARATOR","Advancing enteral feeds after 3 days of trophic feeds of 20-25 mL\u002Fkg birthweight\u002Fday. Advancement of enteral feeds will be by approximately 30 mL\u002Fkg birthweight\u002Fday after 3 days of trophic feeds. Advancement will occur until achieving at least 140 mL\u002Fkg birthweight\u002Fday of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.",[13],"Other: Extended Trophic Feeds (3 days of trophics)",{"label":15,"type":16,"description":17,"interventionNames":18},"Limited Trophic Feeds","EXPERIMENTAL","Advancing enteral feeds after 1 day of trophic feeds of 20-25 mL\u002Fkg birthweight\u002Fday. Advancement of enteral feeds will be by approximately 30 mL\u002Fkg birthweight\u002Fday until achieving at least 140 mL\u002Fkg birthweight\u002Fday of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.",[19],"Other: Limited Trophic Feeds (1 day of trophic feeds)",[21,25],{"type":6,"name":22,"description":17,"armGroupLabels":23,"otherNames":24},"Limited Trophic Feeds (1 day of trophic feeds)",[15],[15],{"type":6,"name":26,"description":11,"armGroupLabels":27,"otherNames":28},"Extended Trophic Feeds (3 days of trophics)",[9],null,[30],{"name":31,"affiliation":5,"role":32},"Gregory C Valentine","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Gregory C Valentine, MD MED FAAP","CONTACT","(206) 543-3200","gcvalent@uw.edu",{"name":40,"role":36,"phone":28,"phoneExt":28,"email":41},"Ariel Salas, MD, MSPH","asalas@uabmc.edu",[43,61,76,91,109,120],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Alabama at Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.80249,33.52066,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":28,"email":41},"Ariel Salas, MD MSPH","205.934.4680",{"facility":62,"status":45,"city":63,"state":64,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of South Florida","Tampa","Florida","33606",{"type":52,"coordinates":67},[68,69],-82.45843,27.94752,{"lat":69,"lon":68},[72],{"name":73,"role":36,"phone":74,"phoneExt":28,"email":75},"Steven Ford, MD","(813) 844-7493","slford2@usf.edu",{"facility":77,"status":45,"city":78,"state":79,"zip":80,"country":49,"countryCode":50,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of Oklahoma","Oklahoma City","Oklahoma","73104",{"type":52,"coordinates":82},[83,84],-97.51643,35.46756,{"lat":84,"lon":83},[87],{"name":88,"role":36,"phone":89,"phoneExt":28,"email":90},"Erynn Bergner, MD","(405) 271-5215","erynn-bergner@ouhsc.edu",{"facility":92,"status":45,"city":93,"state":94,"zip":95,"country":49,"countryCode":50,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Baylor College of Medicine","Houston","Texas","77030",{"type":52,"coordinates":97},[98,99],-95.36327,29.76328,{"lat":99,"lon":98},[102,106],{"name":103,"role":36,"phone":104,"phoneExt":28,"email":105},"Amy B Hair, MD","832-826-1380","abhair@texaschildrens.org",{"name":107,"role":36,"phone":104,"phoneExt":28,"email":108},"Murali Premkumar, MBBS, DCH,DNB,MRCPCH, MS","premkuma@bcm.edu",{"facility":5,"status":45,"city":110,"state":111,"zip":112,"country":49,"countryCode":50,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Seattle","Washington","98195",{"type":52,"coordinates":114},[115,116],-122.33207,47.60621,{"lat":116,"lon":115},[119],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},{"facility":121,"status":122,"city":123,"state":111,"zip":124,"country":49,"countryCode":50,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"St. Joseph's Medical Center","RECRUITING","Tacoma","98405",{"type":52,"coordinates":126},[127,128],-122.44429,47.25288,{"lat":128,"lon":127},[131,133],{"name":35,"role":36,"phone":132,"phoneExt":28,"email":38},"2534266740",{"name":134,"role":36,"phone":132,"phoneExt":28,"email":135},"Stephen Welty, MD","stephen.welty@vmfh.org",{"type":32,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Gregory C. Valentine, MD MED FAAP","Associate Professor, Department of Pediatrics",[140,141,142,143,144],{"name":44,"class":6},{"name":92,"class":6},{"name":62,"class":6},{"name":77,"class":6},{"name":121,"class":145},"UNKNOWN","100584790","phase-3-limited-versus-extended-trophic-feeding-let-feed-trial-100584790",false,"NCT06893939","Limited Versus Extended Trophic Feeding (LET-FEED) Trial","LET-FEED","Inclusion Criteria:\n\n* \\\u003C1500 gram birthweight\n* 25w0d-31w6d at birth\n* Consent to feed donor milk when parent's own milk is not available or of insufficient quantity\n\nExclusion Criteria:\n\n* \\\u003C5th percentile for weight at birth (Fenton growth curve)\n* Parent or legal guardian unable to provide consent within 36 hours after birth\n* Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.)\n* Known genetic condition affecting growth, feeding, or mortality\n* Vasopressor use within first 24 hours after birth (not including hydrocortisone)\n* Considered terminally ill",true,"ALL","0 Hours","36 Hours",{"count":158,"type":159},350,"ESTIMATED","INTERVENTIONAL",[162],"PHASE3","Study Hypothesis\u002FQuestion In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes.\n\nStudy Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL\u002Fkg\u002Fday for one day) or the control group, receiving extended trophic feeding (20 to 25 mL\u002Fkg\u002Fday for three days) prior to advancing enteral feeds until full feeding volume (140 mL\u002Fkg\u002Fday) is achieved.\n\nEligibility Criteria Preterm infants with gestational ages between 25 0\u002F7 and 31 6\u002F7 weeks and a birthweight of \\\u003C1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \\\u003C5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital\u002Fgenetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded.\n\nStudy Intervention\u002FMethods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable.\n\nPrimary Outcome Late-onset sepsis, defined as positive blood, urine, and\u002For cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more.\n\nSecondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.",[165,166,167],"Sepsis","Length of Stay","Mortality",[169,170,171,172,173,174,175,176,177],"Feeding","Nutrition","Prematurity","Very preterm","Trophic","Trophic feeds","Trophic feeding","enteral feeds","sepsis","2025-07-23",{"date":180,"type":181},"2025-07-28","ACTUAL",{"date":183,"type":181},"2025-07-03",{"date":185,"type":159},"2028-03-31",{"name":5,"class":6},6]