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Completed

NCT Number: NCT02575846

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

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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Key information

Conditions

Gastroschisis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

2 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Intake - Human Milk

Dietary Supplement

Comparing formula and human milk

Enteral Intake - Formula

Dietary Supplement

Comparing formula and human milk

Primary outcomes

  1. Length of Hospital Stay

    Time frame: One month

Secondary outcomes

  1. Time to Full Enteral Feeds

    Time frame: Three weeks

  2. Time on Total Parenteral Nutrition

    Time frame: Three weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 15, 2015
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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