An interventional study of Early Feeding Protocol in Gastroschisis, sponsored by University of California, Davis. Recruiting at 2 sites in United States. Open to participants aged 0 Days to 1 Year. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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.
42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 26 interventional studies indexed under Gastroschisis.
Browse Gastroschisis studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Exclusion Criteria:
This 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.
Procedure: Early 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.
Also known as: Early Initiation of Human Milk Feeds
Feasibility of Enrollment in Early Feeding Study Cohort
Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.
Time frame: From prenatal period within the first 24 hours of abdominal closure
Feasibility of Protocol Adherence
Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure.
Time frame: From abdominal closure to 48 hours after closure.
Fidelity to Protocol
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.
Time frame: From abdominal closure through discharge from the hospital, average of 90 days
Protocol Withdrawal Rate
Proportion of enrolled infants who withdraw from the study
Time frame: From time of enrollment (prenatal) to hospital discharge, an average of 90 days
Outcomes of of Adverse Events
This exploratory outcome is measuring the incidence of severe adverse events in neonates enrolled in the early feeding protocol study. Adverse events include: * Necrotizing enterocolitis (\>Stage II) * Sepsis * Abdominal compartment syndrome * Additional abdominal surgeries (excluding primary closure) * Mortality
Time frame: From enrollment through hospital discharge, an average of 90 days
Outcomes of Hospital Admission Duration
This exploratory outcome measures the total duration of length (days) of hospital stay.
Time frame: From birth admission to hospital through discharge, assessed up to 1 year
Outcome of Duration of Parenteral Nutrition
This exploratory outcome measures the total duration of parenteral nutrition (days) in enrolled patients.
Time frame: From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year
Outcome of Feeding Progression
This exploratory outcome measures the feeding progression (time to first feed (days) and time to full feeds (days)) in infants enrolled.
Time frame: From initiation of feeds through achievement of enteral autonomy, assessed up to 1 year
Outcome of Growth Parameters
This exploratory outcomes measures the changes in growth parameters (height, weight) using calculated z-scores (as measured by standard deviations from the mean, presented in percentages relative to average for age).
Time frame: From birth admission to hospital through discharge, assessed up to 1 year
Feasibility of Data Collection of Direct Breastfeeding Practices
Assessment of the feasibility of obtaining information related to breastfeeding practices through electronic medical records, using dichotomous measures of whether parent had direct breastfeeding during hospitalization and at time of discharge (48 hours prior to hospital discharge).
Time frame: Assessed from birth through hospital discharge, an average of 90 days
Plan to share: Yes — After the primary study results are published, individual participant data will be de-identified and made available to qualified researchers upon request, subject to a data use agreement and review by the study team. Access will be granted within 12 months of a successful application, provided the request aligns with the study's scientific objectives, the intended study is IRB approved and adheres to ethical data protection guidelines.
Supporting information: Study protocol, Informed consent form
Time frame: Starting 6 months after publication
Access criteria: The study team will review application requests submitted by interested researchers. The intended study must align with our study's scientific objectives, be IRB approved, and adhere to ethical data protection guidelines.
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