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

Not Applicable

Completed

• Conditions: Gastroschisis
• Interventions: Dietary Supplement: Enteral Intake - Human Milk; Dietary Supplement: Enteral Intake - Formula

• Registration Number: NCT02575846
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2015-11-26
• Primary Completion: 2016-11-11
• Study Completion: 2016-11-11
• Status Verified: 2017-06
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Milk	Enteral Intake - Human Milk	Neonates fed human milk
Formula	Enteral Intake - Formula	Neonates fed formula

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	One month

Secondary Outcome Measures

Name	Time	Method
Time on Total Parenteral Nutrition	Three weeks
Time to Full Enteral Feeds	Three weeks

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States