Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2016
CompletedApril 12, 2024
June 1, 2017
12 months
October 6, 2015
April 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Hospital Stay
One month
Secondary Outcomes (2)
Time to Full Enteral Feeds
Three weeks
Time on Total Parenteral Nutrition
Three weeks
Study Arms (2)
Human Milk
ACTIVE COMPARATORNeonates fed human milk
Formula
PLACEBO COMPARATORNeonates fed formula
Interventions
Eligibility Criteria
You may qualify if:
- \) neonates born with gastroschisis
- \) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study
You may not qualify if:
- \) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(\<1500 grams))
- \) known major chromosomal abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (4)
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.
PMID: 23519369BACKGROUNDSydorak 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.
PMID: 12483626BACKGROUNDMastromarino 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.
PMID: 24970346BACKGROUNDGomez-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.
PMID: 23752082BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Obinna O Adibe, MD, MHS
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2015
First Posted
October 15, 2015
Study Start
November 26, 2015
Primary Completion
November 11, 2016
Study Completion
November 11, 2016
Last Updated
April 12, 2024
Record last verified: 2017-06