Early Feeding for Gastroschisis

(GAIN Trial)

Recruiting at 1 trial location

Overseen By Nicole Cacho, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Ionotropic medications

Disqualifiers: Complex gastroschisis, Major anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: From abdominal closure through discharge, average of 90 days

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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

Born at ≥ 34 weeks' gestation

My newborn has gastroschisis without complications.

My heart and blood circulation are stable.

Exclusion Criteria

Presence of any major congenital anomalies

Neonates whose care is considered to be futile or those undergoing re-direction of care

Any patient deemed unfit for participation by study investigator(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Prenatal period

Treatment

Neonates with gastroschisis undergo surgical repair and are initiated on early feeding protocol within 48 hours post-surgery

From abdominal closure through discharge, average of 90 days

Follow-up

Participants are monitored for safety, growth parameters, and feeding progression after treatment

Assessed up to 1 year

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?

Group I: Early Feeding Protocol Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

The Gerber Foundation

Collaborator

Trials

45

Recruited

6,200+

University of California Fetal Consortium

Collaborator

Trials

1

Recruited

20+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jpc.16657

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34193345/

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, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06878950

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:.

4. bspghan.org.uk bspghan.org.uk/wp-content/uploads/2024/09/j-paediatrics-child-health-2024-jyoti-evaluation-of-gastroschisis-feeding-protocol-a-retrospective-cohort-study.pdf

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.2

A 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231808/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346821003134

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.

8. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2692

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.

9. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-019-1858-z

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 ...