Early Feeds in Gastroschisis (GAIN)

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroschisis
• Intervention / Treatment: Procedure: Early Feeding Protocol

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Cacho, DO; Phone Number: (916) 282-2507; Email: ntcacho@ucdavis.edu
• Study Contact Backup: Name: Geoanna Bautista, MD; Phone Number: (916) 282-2507; Email: gmbautista@ucdavis.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • University of California Los Angeles
      • Contact: Kara Calkins, MD; Email: kcalkins@mednet.ucla.edu
      • Contact: Dan Deugarte, MD; Email: ddeugarte@mednet.ucla.edu
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Children's Hospital
      • Contact: Nicole Cacho, DO; Phone Number: 916-282-2507
      • Contact: Geoanna Bautista, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Feeding Protocol Group; 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.	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.; Other Names: Early Initiation of Human Milk Feeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Enrollment in Early Feeding Study Cohort	Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.	From prenatal period within the first 24 hours of abdominal closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of of Adverse Events	This exploratory outcome is measuring the incidence of severe adverse events in neonates enrolled in the early feeding protocol study. Adverse events include: Necrotizing enterocolitis (>Stage II); Sepsis; Abdominal compartment syndrome; Additional abdominal surgeries (excluding primary closure); Mortality	From enrollment through hospital discharge, an average of 90 days
Outcomes of Hospital Admission Duration	This exploratory outcome measures the total duration of length (days) of hospital stay.	From birth admission to hospital through discharge, assessed up to 1 year
Outcome of Duration of Parenteral Nutrition	This exploratory outcome measures the total duration of parenteral nutrition (days) in enrolled patients.	From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year
Outcome of Feeding Progression	This exploratory outcome measures the feeding progression (time to first feed (days) and time to full feeds (days)) in infants enrolled.	From initiation of feeds through achievement of enteral autonomy, assessed up to 1 year
Outcome of Growth Parameters	This exploratory outcomes measures the changes in growth parameters (height, weight) using calculated z-scores (as measured by standard deviations from the mean, presented in percentages relative to average for age).	From birth admission to hospital through discharge, assessed up to 1 year
Feasibility of Data Collection of Direct Breastfeeding Practices	Assessment of the feasibility of obtaining information related to breastfeeding practices through electronic medical records, using dichotomous measures of whether parent had direct breastfeeding during hospitalization and at time of discharge (48 hours prior to hospital discharge).	Assessed from birth through hospital discharge, an average of 90 days

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: University of California, Los Angeles; National Center for Advancing Translational Sciences (NCATS); The Gerber Foundation; University of California Fetal Consortium
• Investigators: Principal Investigator: Nicole Cacho, DO, University of California, Davis; Principal Investigator: Geoanna Bautista, MD, University of California, Davis

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Gastroschisis; Early feeds in Gastroschisis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Musculoskeletal Abnormalities; Congenital Abnormalities; Hernia; Hernia, Abdominal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Gastroschisis
• Other Study ID Numbers: 2216195; UL1TR001860 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the primary study results are published, individual participant data will be de-identified and made available to qualified researchers upon request, subject to a data use agreement and review by the study team. Access will be granted within 12 months of a successful application, provided the request aligns with the study's scientific objectives, the intended study is IRB approved and adheres to ethical data protection guidelines.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: The study team will review application requests submitted by interested researchers. The intended study must align with our study's scientific objectives, be IRB approved, and adhere to ethical data protection guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No