Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

April 11, 2024 updated by: Duke University
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 hours to 2 days (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1) neonates born with gastroschisis
  • 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study

Exclusion Criteria:

  • 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(<1500 grams))
  • 2) known major chromosomal abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Human Milk
Neonates fed human milk
Dietary supplement: Enteral Intake - Human Milk
Comparing formula and human milk
Placebo Comparator: Formula
Neonates fed formula
Dietary supplement: Enteral Intake - Formula
Comparing formula and human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Hospital Stay
Time Frame: One month
One month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Full Enteral Feeds
Time Frame: Three weeks
Three weeks
Time on Total Parenteral Nutrition
Time Frame: Three weeks
Three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Obinna O Adibe, MD, MHS, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2015

Primary Completion (Actual)

November 11, 2016

Study Completion (Actual)

November 11, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimated)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00056976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroschisis

Clinical Trials on Enteral Intake - Human Milk

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe