Early Feeds in Gastroschisis
ConditionGastroschisis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates with presumed simple gastroschisis
Born at ≥ 34 weeks' gestation
Hemodynamically stable
Consented within 48 hours after abdominal closure
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Early Feeding Protocol
Procedure/SurgeryThe intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Early Feeding Protocol GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 closureSecondary outcomes
1
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.2
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 days3
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 daysOther outcomes
1
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 days2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
The Gerber Foundation
Collaborator
University of California, Los Angeles
Collaborator
University of California Fetal Consortium
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov