[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06878950":3,"trial-entities:NCT06878950":136,"trial-summary:NCT06878950":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":76,"locations":78,"central_contacts":110,"overall_officials":116,"references":120,"see_also_links":135},"NCT06878950","2216195","Early Feeds in Gastroschisis","The GAIN Study: The Gastroschisis And Early Infant Nutrition Study","RECRUITING","2029-02-01","2026-03","2026-03-17","2025-02-24","University of California, Davis","OTHER",false,"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.",null,[19],"Gastroschisis",[19,21],"Early feeds in Gastroschisis","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"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.",[35],"Early Feeding Protocol Group",[37],"Early Initiation of Human Milk Feeds",[39],{"measure":40,"description":41,"timeFrame":42},"Feasibility of Enrollment in Early Feeding Study Cohort","Proportion of eligible neonates with gastroschisis whose parents\u002Fguardians consent to enrollment in the study.","From prenatal period within the first 24 hours of abdominal closure",[44,48,52],{"measure":45,"description":46,"timeFrame":47},"Feasibility of Protocol Adherence","Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure.","From abdominal closure to 48 hours after closure.",{"measure":49,"description":50,"timeFrame":51},"Fidelity to Protocol","Proportion of enrolled infants with gastroschisis who adhere to the remainder of the protocol without major deviations. Feasibility will be assessed using protocol adherence tracking forms completed by study team.","From abdominal closure through discharge from the hospital, average of 90 days",{"measure":53,"description":54,"timeFrame":55},"Protocol Withdrawal Rate","Proportion of enrolled infants who withdraw from the study","From time of enrollment (prenatal) to hospital discharge, an average of 90 days","ALL","0 Days","1 Year",{"inclusion":60,"exclusion":67,"raw_text":75},[61,62,63,64,65,66],"Neonates with presumed simple gastroschisis","Born at ≥ 34 weeks' gestation","Hemodynamically stable","Consented within 48 hours after abdominal closure","Mothers who are ≥16 years old","Mothers who speak English or Spanish",[68,69,70,71,72,73,74],"Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)","Presence of any major congenital anomalies","Neonates who are receiving ionotropic medications","Neonates who are wards of the state","Neonates whose care is considered to be futile or those undergoing re-direction of care","Neonates participating in another interventional trial","Any patient deemed unfit for participation by study investigator(s)","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)",[77],"CHILD",[79,97],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":94},"University of California Los Angeles","NOT_YET_RECRUITING","Los Angeles","California","90095","United States",[87,91],{"name":88,"role":89,"email":90},"Kara Calkins, MD","CONTACT","kcalkins@mednet.ucla.edu",{"name":92,"role":89,"email":93},"Dan Deugarte, MD","ddeugarte@mednet.ucla.edu",{"lat":95,"lon":96},34.05223,-118.24368,{"facility":98,"status":8,"city":99,"state":83,"zip":100,"country":85,"contacts":101,"geoPoint":107},"UC Davis Children's Hospital","Sacramento","95817",[102,105],{"name":103,"role":89,"phone":104},"Nicole Cacho, DO","916-282-2507",{"name":106,"role":89},"Geoanna Bautista, MD",{"lat":108,"lon":109},38.58157,-121.4944,[111,114],{"name":103,"role":89,"phone":112,"email":113},"(916) 282-2507","ntcacho@ucdavis.edu",{"name":106,"role":89,"phone":112,"email":115},"gmbautista@ucdavis.edu",[117,119],{"name":103,"affiliation":13,"role":118},"PRINCIPAL_INVESTIGATOR",{"name":106,"affiliation":13,"role":118},[121,125,128,131],{"pmid":122,"type":123,"citation":124},"31801489","BACKGROUND","Hobson D, Spence K, Trivedi A, Thomas G. Differences in attitudes to feeding post repair of Gastroschisis and development of a standardized feeding protocol. BMC Pediatr. 2019 Dec 4;19(1):475. doi: 10.1186\u002Fs12887-019-1858-z.",{"pmid":126,"type":123,"citation":127},"31704046","DeUgarte DA, Calkins KL, Guner Y, Kim J, Kling K, Kramer K, Lee H, Lusk L, Saadai P, Uy C, Rottkamp C; University of California Fetal Consortium. Adherence to and outcomes of a University-Consortium gastroschisis pathway. J Pediatr Surg. 2020 Jan;55(1):45-48. doi: 10.1016\u002Fj.jpedsurg.2019.09.048. Epub 2019 Oct 27.",{"pmid":129,"type":123,"citation":130},"39206671","Jyoti J, James-Nunez K, Spence K, Parkinson B, Thomas G, Trivedi A. Evaluation of gastroschisis feeding protocol: A retrospective cohort study. J Paediatr Child Health. 2024 Nov;60(11):675-679. doi: 10.1111\u002Fjpc.16657. Epub 2024 Aug 29.",{"pmid":132,"type":133,"citation":134},"42298737","DERIVED","Cacho NT, Cera AJ, Tancredi DJ, Wieck MM, Anderson JE, Leegwater AJ, Uy CC, Guner YS, DeUgarte DA, Rosenthal JL, Calkins KL, Bautista GM; University of California Fetal Consortium (UCfC). GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis. Pilot Feasibility Stud. 2026 Jun 15. doi: 10.1186\u002Fs40814-026-01860-4. Online ahead of print.",[],{"nct_id":4,"conditions":137,"biomarkers":138},[19],[],{"nct_id":4,"found":140,"summary":141,"prompt_version":150},true,{"design":142,"status":143,"heading":6,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.","completed","This study is looking at whether it's possible to start feeding babies with gastroschisis (a condition where intestines are outside the body at birth) sooner than usual. The study will test an \"Early Feeding Protocol.\" This involves removing a tube called a Replogle within 24 hours of surgery and starting introductory feeds within 48 hours of surgery. You might be able to join if your baby has simple gastroschisis, was born at 34 weeks or more, is stable, and you are at least 16 years old and speak English or Spanish. The main goal is to see if it's practical to enroll babies in a study like this. The study plans to include 20 babies, but its current status is unclear.","The primary endpoint is measured from the prenatal period within the first 24 hours of abdominal closure.",121,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]