Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
Completed
Conditions studied: Infant, Very Low Birth Weight
In brief
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection.
Key facts
- Study ID
- NCT02573779
- Run by
- Baylor College of Medicine
- People needed
- 125
- Starts
- 2015-07-10
- Expected to finish
- 2018-10-25
- Last updated by the study team
- 2025-02-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants less than 72 hours old and less than 1500 g birth weight, who have reasonable expectation of survival and can adhere to a feeding protocol involving mother's own milk and/or donor milk that will include fortification using Prolacta and potentially human cream.
You may not qualify if…
- Exclusion criteria will include birth weight greater than 1500 g, age > 72 hours old, major congenital anomalies, clinically significant heart disease, abdominal wall defects and/or intestinal atresias, severe perinatal hypoxia, or otherwise less than reasonable expectation of survival through the study period.
Where it is running
- Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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