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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-26

Study Completion Date

2016-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroschisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human Milk

Neonates fed human milk

Group Type ACTIVE_COMPARATOR

Enteral Intake - Human Milk

Intervention Type DIETARY_SUPPLEMENT

Comparing formula and human milk

Formula

Neonates fed formula

Group Type PLACEBO_COMPARATOR

Enteral Intake - Formula

Intervention Type DIETARY_SUPPLEMENT

Comparing formula and human milk

Interventions

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Enteral Intake - Human Milk

Comparing formula and human milk

Intervention Type DIETARY_SUPPLEMENT

Enteral Intake - Formula

Comparing formula and human milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes