Early Feeding for Gastroschisis
(GAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of early feeding in babies born with gastroschisis, a condition where the intestines are outside the body at birth. The trial aims to determine if feeding human milk soon after surgery aids recovery. It focuses on babies born at least 34 weeks into pregnancy who are stable post-surgery. This trial targets infants without other major health complications. As an unphased trial, it provides a unique opportunity to contribute to understanding how early feeding can aid recovery in infants with gastroschisis.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that the Early Feeding Protocol is safe for neonates with gastroschisis?
Research has shown that early feeding for infants with gastroschisis can be safe. One study found that increasing food by 20 mL per kilogram of the baby's weight each day helped them reach feeding goals faster and reduced hospital stays. This indicates the feeding method was well-tolerated. Another source suggests that increasing feeds by 12–30 mL per kilogram every 24–48 hours might improve feed tolerance and lower the risk of complications. While the trial continues to investigate serious side effects, current evidence supports the safety of early feeding in these infants.12345
Why are researchers excited about this trial?
Researchers are excited about the Early Feeding Protocol for gastroschisis because it aims to kickstart a newborn's feeding process much faster than traditional methods. Typically, babies with gastroschisis are fed intravenously while their intestines recover, which can delay oral feeding for weeks. However, this new protocol introduces human milk feeds within just 48 hours of surgery, potentially speeding up recovery and promoting oral motor skill development. By advancing feeds based on tolerance and clinical assessment, the protocol could significantly reduce hospital stays and improve outcomes for these vulnerable infants.
What evidence suggests that this early feeding protocol is effective for gastroschisis?
Research has shown that a set feeding plan for infants with gastroschisis can be beneficial. In this trial, participants in the Early Feeding Protocol Group will follow a specific plan to begin human milk feeds within 48 hours of surgical repair. Studies have found that such plans enable babies to start feeding by mouth about three days earlier than those without a set plan. This method also helps develop essential feeding skills. Initiating feeds early with human milk soon after surgery aims to support growth and improve overall outcomes. Evidence suggests that early feeding can aid these infants in recovering and growing better post-surgery.26789
Who Is on the Research Team?
Nicole Cacho, DO
Principal Investigator
University of California, Davis
Geoanna Bautista, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for newborns with gastroschisis, where their intestines are outside the body at birth. The study will include those who meet specific health criteria set by the researchers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Neonates with gastroschisis undergo surgical repair and are initiated on early feeding protocol within 48 hours post-surgery
Follow-up
Participants are monitored for safety, growth parameters, and feeding progression after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Early Feeding Protocol
Trial Overview
The study is testing an Early Feeding Protocol to see if it's possible and safe to start feeding these infants sooner than currently recommended.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
The Gerber Foundation
Collaborator
University of California Fetal Consortium
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
University of California, Los Angeles
Collaborator
Citations
Evaluation of gastroschisis feeding protocol: A ...
The primary outcomes were initiation of enteral feeds, suck feeds and breastfeeding at discharge. The secondary outcome was growth measured by Z ...
The effect of standardized feeding protocol on early ...
Standardized feeding protocols resulted in fewer days to first enteral feeding by 3.19 days (95% CI: -4.73, -1.66, p < 0.0001) than non-protocolized feeding, ...
Study Details | NCT06878950 | Early Feeds in Gastroschisis
This exploratory outcome is measuring the incidence of severe adverse events in neonates enrolled in the early feeding protocol study. Adverse events include:.
Evaluation of gastroschisis feeding protocol
The primary outcomes were initiation of enteral feeds, suck feeds and breastfeeding at discharge. The secondary outcome was growth measured by Z-score of weight ...
5.
journals.sagepub.com
journals.sagepub.com/doi/10.1177/19345798251327370?icid=int.sj-abstract.similar-articles.2A survey of neonatal intensive care units in Canada
We developed an 18-item survey with open-ended questions focused on feeding and nutrition among infants with gastroschisis.
Feeding practices for infants with gastroschisis: A survey of ...
They also noted that advancing feeds 12–30 mL/kg every 24–48 hours may promote feeding tolerance and reduce the risk of necrotizing ...
The role of feeding advancement strategy on length of stay ...
A nutritional protocol that incorporated 20 ml/kg/day feeding advancements was found to be safe and resulted in faster attainment of goal feeds and shorter LOS.
Association between consensus‐based nutrition pathway and ...
The University of California Fetal Consortium published that 55% of infants with gastroschisis develop growth faltering by hospital discharge.
Differences in attitudes to feeding post repair of Gastroschisis ...
The identified outcomes to measure the potential success of the protocol were duration of TPN, length of central venous line (CVL) use, the time ...
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