Evaluating early feeding in newborns with gastroschisis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility of starting early feeding protocols in neonates diagnosed with gastroschisis, a condition where the intestines are located outside the body at birth. The intervention involves initiating feeds shortly after surgical closure of the abdominal wall. Eligible participants include hemodynamically stable neonates born at or after 34 weeks of gestation, with parental consent obtained within 48 hours post-surgery. The study aims to determine if early feeding can be safely implemented in this vulnerable population.

Why it matters

Who can join: the full rules

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)

Where it's running

• UC Davis Children's Hospital
  Sacramento, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Not yet recruiting

Study contacts

• Principal investigator: Nicole Cacho, DO — University of California, Davis
• Study coordinator: Nicole Cacho, DO
• Email: ntcacho@ucdavis.edu
• Phone: (916) 282-2507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.