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Recruiting NCT06878950

Early Feeds in Gastroschisis

No phase Interventional Gastroschisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Feeding Protocol.
Who it may be relevant to
Registry conditions: Gastroschisis. Basic parameters: 0 Days — 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility of Enrollment in Early Feeding Study Cohort [Time frame: From prenatal period within the first 24 hours of abdominal closure]
Secondary outcome measures (3)
  • Feasibility of Protocol Adherence [Time frame: From abdominal closure to 48 hours after closure.]
  • Fidelity to Protocol [Time frame: From abdominal closure through discharge from the hospital, average of 90 days]
  • Protocol Withdrawal Rate [Time frame: From time of enrollment (prenatal) to hospital discharge, an average of 90 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of California Los Angeles — Los Angeles
  • UC Davis Children's Hospital — Sacramento

Publications

  • 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. PMID 31801489
  • 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. PMID 31704046
  • 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. PMID 39206671
  • 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/s40814-026-01860-4. Online ahead of print. PMID 42298737

Identifiers

NCT: NCT06878950 · 2216195 · UL1TR001860

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗