RecruitingNot Applicable

Early Feeds in Gastroschisis

United States20 participantsStarted 2025-02-24

Plain-language 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.

Who can participate

Age range

0 Days – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Enrollment in Early Feeding Study Cohort

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

Trial details

NCT IDNCT06878950

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Nicole Cacho, DO

(916) 282-2507 ntcacho@ucdavis.edu

View on ClinicalTrials.gov More Gastroschisis trials

Who can participate

Age range

0 Days – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.