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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02575846

Enrollment

Registered

2015-10-15

Start date

2015-11-26

Completion date

2016-11-11

Last updated

2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroschisis

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.

Interventions

DIETARY_SUPPLEMENTEnteral Intake - Human Milk

Comparing formula and human milk

DIETARY_SUPPLEMENTEnteral Intake - Formula

Comparing formula and human milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Hours to 48 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Length of Hospital Stay	One month

Secondary

Measure	Time frame
Time to Full Enteral Feeds	Three weeks
Time on Total Parenteral Nutrition	Three weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026