NCT06878950

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Feb 2025Feb 2029

Study Start

First participant enrolled

February 24, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

March 4, 2025

Last Update Submit

March 13, 2026

Conditions

Gastroschisis

Keywords

GastroschisisEarly feeds in Gastroschisis

Outcome Measures

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.

    From prenatal period within the first 24 hours of abdominal closure

Secondary Outcomes (3)

  • Feasibility of Protocol Adherence

    From abdominal closure to 48 hours after closure.

  • Fidelity to Protocol

    From abdominal closure through discharge from the hospital, average of 90 days

  • Protocol Withdrawal Rate

    From time of enrollment (prenatal) to hospital discharge, an average of 90 days

Other Outcomes (6)

  • Outcomes of of Adverse Events

    From enrollment through hospital discharge, an average of 90 days

  • Outcomes of Hospital Admission Duration

    From birth admission to hospital through discharge, assessed up to 1 year

  • Outcome of Duration of Parenteral Nutrition

    From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year

  • +3 more other outcomes

Study Arms (1)

Early Feeding Protocol Group

EXPERIMENTAL

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

Interventions

Early Feeding ProtocolPROCEDURE

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
Early Feeding Protocol Group

Eligibility Criteria

Age0 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

UC Davis Children's Hospital

Sacramento, California, 95817, United States

RECRUITING

Related Publications (3)

  • Hobson D, Spence K, Trivedi A, Thomas G. Differences in attitudes to feeding post repair of Gastroschisis and development of a standardized feeding protocol. BMC Pediatr. 2019 Dec 4;19(1):475. doi: 10.1186/s12887-019-1858-z.

    PMID: 31801489BACKGROUND

  • DeUgarte DA, Calkins KL, Guner Y, Kim J, Kling K, Kramer K, Lee H, Lusk L, Saadai P, Uy C, Rottkamp C; University of California Fetal Consortium. Adherence to and outcomes of a University-Consortium gastroschisis pathway. J Pediatr Surg. 2020 Jan;55(1):45-48. doi: 10.1016/j.jpedsurg.2019.09.048. Epub 2019 Oct 27.

    PMID: 31704046BACKGROUND

  • Jyoti J, James-Nunez K, Spence K, Parkinson B, Thomas G, Trivedi A. Evaluation of gastroschisis feeding protocol: A retrospective cohort study. J Paediatr Child Health. 2024 Nov;60(11):675-679. doi: 10.1111/jpc.16657. Epub 2024 Aug 29.

    PMID: 39206671BACKGROUND

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Cacho, DO

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Geoanna Bautista, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Cacho, DO

CONTACT

(916) 282-2507ntcacho@ucdavis.edu

Geoanna Bautista, MD

CONTACT

(916) 282-2507gmbautista@ucdavis.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 17, 2025

Study Start

February 24, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
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.

Locations

US(2)