Gastroschisis
Conditions
Keywords
Gastroschisis, Early feeds in Gastroschisis
Brief 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.
Interventions
PROCEDUREEarly Feeding Protocol
The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
Sponsors
University of California, Davis
The Gerber Foundation
University of California, Los Angeles
University of California Fetal Consortium
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment in Early Feeding Study Cohort | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Protocol Adherence | From abdominal closure to 48 hours after closure. | Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure. |
| Fidelity to Protocol | 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. |
| Protocol Withdrawal Rate | From time of enrollment (prenatal) to hospital discharge, an average of 90 days | Proportion of enrolled infants who withdraw from the study |
Countries
United States
Contacts
CONTACTNicole Cacho, DO
CONTACTGeoanna Bautista, MD
PRINCIPAL_INVESTIGATORNicole Cacho, DO
University of California, Davis
PRINCIPAL_INVESTIGATORGeoanna Bautista, MD
University of California, Davis
Outcome results
None listed