Early Feeds in Gastroschisis
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT06878950
- Status
- Recruiting
Conditions
- Gastroschisis
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Days - 1 Year
- Healthy Volunteers
- Not accepted
Interventions
- Early Feeding Protocol — PROCEDUREThe intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
Study Details
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.
Key Dates
- Start date
- Feb 24, 2025
- Status verified
- Mar 2026
- Primary completion
- Feb 1, 2028
- Completion
- Feb 1, 2029
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Early Feeding Protocol GroupThis 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.
Primary Outcome Measure
Feasibility of Enrollment in Early Feeding Study Cohort [ Time Frame: From prenatal period within the first 24 hours of abdominal closure ]
Central Contacts
- Nicole Cacho, DO(916) 282-2507
- Geoanna Bautista, MD(916) 282-2507
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | Kara Calkins, MD Dan Deugarte, MD |
| UC Davis Children's Hospital | Sacramento | California | 95817 | Nicole Cacho, DO 916-282-2507 Geoanna Bautista, MD |
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