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NCT Number: NCT06878950

Early Feeds in Gastroschisis

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.

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Key information

Conditions

Gastroschisis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early Feeding Protocol

Procedure

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

Primary outcomes

  1. Feasibility of Enrollment in Early Feeding Study Cohort

    Time frame: From prenatal period within the first 24 hours of abdominal closure

    Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.

Secondary outcomes

  1. Feasibility of Protocol Adherence

    Time frame: From abdominal closure to 48 hours after closure.

    Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure.

  2. Fidelity to Protocol

    Time frame: From abdominal closure through discharge from the hospital, average of 90 days

    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.

  3. Protocol Withdrawal Rate

    Time frame: From time of enrollment (prenatal) to hospital discharge, an average of 90 days

    Proportion of enrolled infants who withdraw from the study

Other outcomes

  1. Outcomes of of Adverse Events

    Time frame: From enrollment through hospital discharge, an average of 90 days

    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

  2. Outcomes of Hospital Admission Duration

    Time frame: From birth admission to hospital through discharge, assessed up to 1 year

    This exploratory outcome measures the total duration of length (days) of hospital stay.

  3. Outcome of Duration of Parenteral Nutrition

    Time frame: From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year

    This exploratory outcome measures the total duration of parenteral nutrition (days) in enrolled patients.

  4. Outcome of Feeding Progression

    Time frame: From initiation of feeds through achievement of enteral autonomy, assessed up to 1 year

    This exploratory outcome measures the feeding progression (time to first feed (days) and time to full feeds (days)) in infants enrolled.

  5. Outcome of Growth Parameters

    Time frame: From birth admission to hospital through discharge, assessed up to 1 year

    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).

  6. Feasibility of Data Collection of Direct Breastfeeding Practices

    Time frame: Assessed from birth through hospital discharge, an average of 90 days

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Geoanna Bautista, MD

CONTACT

[email protected]

(916) 282-2507

Nicole Cacho, DO

CONTACT

[email protected]

(916) 282-2507

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • The Gerber Foundation
  • University of California Fetal Consortium
  • University of California, Los Angeles

Registry information

Official study title

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

Acronym: GAIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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