RECRUITING

Early Feeds in Gastroschisis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

Quick Facts

Study Start:2025-02-24
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06878950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Neonates with presumed simple gastroschisis
  2. * Born at ≥ 34 weeks' gestation
  3. * Hemodynamically stable
  4. * Consented within 48 hours after abdominal closure
  5. * Mothers who are ≥16 years old
  6. * Mothers who speak English or Spanish
  1. * Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
  2. * Presence of any major congenital anomalies
  3. * Neonates who are receiving ionotropic medications
  4. * Neonates who are wards of the state
  5. * Neonates whose care is considered to be futile or those undergoing re-direction of care
  6. * Neonates participating in another interventional trial
  7. * Any patient deemed unfit for participation by study investigator(s)

Contacts and Locations

Study Contact

Nicole Cacho, DO
CONTACT
(916) 282-2507
ntcacho@ucdavis.edu
Geoanna Bautista, MD
CONTACT
(916) 282-2507
gmbautista@ucdavis.edu

Principal Investigator

Nicole Cacho, DO
PRINCIPAL_INVESTIGATOR
University of California, Davis
Geoanna Bautista, MD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90095
United States
UC Davis Children's Hospital
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Nicole Cacho, DO, PRINCIPAL_INVESTIGATOR, University of California, Davis
  • Geoanna Bautista, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2029-02-01

Terms related to this study

Keywords Provided by Researchers

  • Gastroschisis
  • Early feeds in Gastroschisis

Additional Relevant MeSH Terms

  • Gastroschisis