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

Duke University

Status: Completed

Conditions: Gastroschisis

Treatments: Dietary Supplement: Enteral Intake - Formula; Dietary Supplement: Enteral Intake - Human Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02575846

Pro00056976

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 2 to 48 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups, including a placebo group

Human Milk

Active Comparator group

Description:

Neonates fed human milk

Treatment:

Dietary Supplement: Enteral Intake - Human Milk

Formula

Placebo Comparator group

Description:

Neonates fed formula

Treatment:

Dietary Supplement: Enteral Intake - Formula