[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583640":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":28,"locations":36,"responsibleParty":72,"collaborators":74,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":32,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":60,"whyStopped":32,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Feeding Protocol Group","EXPERIMENTAL","This arm involves neonates with presumed simple gastroschisis who will be subjected to an early feeding protocol. The protocol specifies initiating human milk feeds within 48 hours of surgical repair of gastroschisis. Feeds are advanced based on tolerance and clinical assessment, with a focus on promoting oral motor skill development.",[13],"Procedure: Early Feeding Protocol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Early Feeding Protocol","The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.",[9],[21],"Early Initiation of Human Milk Feeds",[23,26],{"name":24,"affiliation":5,"role":25},"Nicole Cacho, DO","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Geoanna Bautista, MD",[29,34],{"name":24,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","(916) 282-2507",null,"ntcacho@ucdavis.edu",{"name":27,"role":30,"phone":31,"phoneExt":32,"email":35},"gmbautista@ucdavis.edu",[37,58],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of California Los Angeles","NOT_YET_RECRUITING","Los Angeles","California","90095","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.24368,34.05223,{"lat":49,"lon":48},[52,55],{"name":53,"role":30,"phone":32,"phoneExt":32,"email":54},"Kara Calkins, MD","kcalkins@mednet.ucla.edu",{"name":56,"role":30,"phone":32,"phoneExt":32,"email":57},"Dan Deugarte, MD","ddeugarte@mednet.ucla.edu",{"facility":59,"status":60,"city":61,"state":41,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"UC Davis Children's Hospital","RECRUITING","Sacramento","95817",{"type":46,"coordinates":64},[65,66],-121.4944,38.58157,{"lat":66,"lon":65},[69,71],{"name":24,"role":30,"phone":70,"phoneExt":32,"email":32},"916-282-2507",{"name":27,"role":30,"phone":32,"phoneExt":32,"email":32},{"type":73,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[75,77,79,82],{"name":76,"class":6},"The Gerber Foundation",{"name":78,"class":6},"University of California, Los Angeles",{"name":80,"class":81},"University of California Fetal Consortium","UNKNOWN",{"name":83,"class":84},"National Center for Advancing Translational Sciences (NCATS)","NIH","100583640","early-feeds-in-gastroschisis-100583640",false,"NCT06878950","Early Feeds in Gastroschisis","The GAIN Study: The Gastroschisis And Early Infant Nutrition Study","GAIN","Inclusion Criteria:\n\n* Neonates with presumed simple gastroschisis\n* Born at ≥ 34 weeks' gestation\n* Hemodynamically stable\n* Consented within 48 hours after abdominal closure\n* Mothers who are ≥16 years old\n* Mothers who speak English or Spanish\n\nExclusion Criteria:\n\n* Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)\n* Presence of any major congenital anomalies\n* Neonates who are receiving ionotropic medications\n* Neonates who are wards of the state\n* Neonates whose care is considered to be futile or those undergoing re-direction of care\n* Neonates participating in another interventional trial\n* Any patient deemed unfit for participation by study investigator(s)","ALL","0 Days","1 Year",{"count":97,"type":98},20,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.",[104],"Gastroschisis",[104,106],"Early feeds in Gastroschisis","2026-03-13",{"date":109,"type":110},"2026-03-17","ACTUAL",{"date":112,"type":110},"2025-02-24",{"date":114,"type":98},"2029-02-01",{"name":5,"class":6},2]