CompletedNot Applicable

Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk

United States125 participantsStarted 2015-07-10

Plain-language summary

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.

Who can participate

Age range3 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Intestinal Microbiome Diversity

Timeframe: 6 weeks

Hospital Length of Stay

Timeframe: Birth to discharge

Weight Gain

Timeframe: 6-10 weeks

Linear Growth

Timeframe: 6-10 weeks

Head Circumference Growth

Timeframe: 6-10 weeks

Trial details

NCT IDNCT02573779

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-09-30

Results submitted2019-12-20

View on ClinicalTrials.gov More Infant, Very Low Birth Weight trials