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NCT02575846 Clinical Trial

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

Gastroschisis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02575846
Other study ID # Pro00056976
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2015
Est. completion date November 11, 2016

Study information
Verified date June 2017
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date November 11, 2016
Est. primary completion date November 11, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Hours to 48 Hours
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Enteral Intake - Human Milk
Comparing formula and human milk
• Enteral Intake - Formula
Comparing formula and human milk

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Gomez-Llorente C, Plaza-Diaz J, Aguilera M, Munoz-Quezada S, Bermudez-Brito M, Peso-Echarri P, Martinez-Silla R, Vasallo-Morillas MI, Campana-Martin L, Vives-Pinera I, Ballesta-Martinez MJ, Gil A. Three main factors define changes in fecal microbiota associated with feeding modality in infants. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):461-6. doi: 10.1097/MPG.0b013e31829d519a. — View Citation

Kohler JA Sr, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013 Aug;33(8):627-30. doi: 10.1038/jp.2013.27. Epub 2013 Mar 21. — View Citation

Mastromarino P, Capobianco D, Campagna G, Laforgia N, Drimaco P, Dileone A, Baldassarre ME. Correlation between lactoferrin and beneficial microbiota in breast milk and infant's feces. Biometals. 2014 Oct;27(5):1077-86. doi: 10.1007/s10534-014-9762-3. Epub 2014 Jun 27. — View Citation

Sydorak RM, Nijagal A, Sbragia L, Hirose S, Tsao K, Phibbs RH, Schmitt SK, Lee H, Farmer DL, Harrison MR, Albanese CT. Gastroschisis: small hole, big cost. J Pediatr Surg. 2002 Dec;37(12):1669-72. doi: 10.1053/jpsu.2002.36689. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Length of Hospital Stay One month
Secondary Time to Full Enteral Feeds Three weeks
Secondary Time on Total Parenteral Nutrition Three weeks
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