Clinical trial NCT06878950: Early Feeds in Gastroschisis
Official title: The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroschisis
Keywords: Gastroschisis
Early feeds in Gastroschisis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
name: University of California, Los Angeles
name: University of California Fetal Consortium
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2025-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Feasibility of Enrollment in Early Feeding Study Cohort
timeFrame: From prenatal period within the first 24 hours of abdominal closure
Secondary outcomes:
measure: Feasibility of Protocol Adherence
timeFrame: From abdominal closure to 48 hours after closure.
measure: Fidelity to Protocol
timeFrame: From abdominal closure through discharge from the hospital, average of 90 days
measure: Protocol Withdrawal Rate
timeFrame: From time of enrollment (prenatal) to hospital discharge, an average of 90 days
Other outcomes:
measure: Outcomes of of Adverse Events
timeFrame: From enrollment through hospital discharge, an average of 90 days
measure: Outcomes of Hospital Admission Duration
timeFrame: From birth admission to hospital through discharge, assessed up to 1 year
measure: Outcome of Duration of Parenteral Nutrition
timeFrame: From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year
measure: Outcome of Feeding Progression
timeFrame: From initiation of feeds through achievement of enteral autonomy, assessed up to 1 year
measure: Outcome of Growth Parameters
timeFrame: From birth admission to hospital through discharge, assessed up to 1 year
measure: Feasibility of Data Collection of Direct Breastfeeding Practices
timeFrame: Assessed from birth through hospital discharge, an average of 90 days
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: UC Davis Children's Hospital
state: California
Study officials:
affiliation: University of California, Davis
name: Nicole Cacho, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Geoanna Bautista, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s12887-019-1858-z.
citation: 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/j.jpedsurg.2019.09.048. Epub 2019 Oct 27.
citation: 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/jpc.16657. Epub 2024 Aug 29.