N/A
N=117
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
Infant, Very Low Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT02573779 ↗Enrolled (actual)
117
Serious AEs
29.1%
Results posted
Apr 2020
Primary outcome: Primary: Intestinal Microbiome Diversity — 55.7; 46.3 taxa represented
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observational - no intervention (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal Microbiome Diversity |
55.7; 46.3 | — |
| PRIMARY Hospital Length of Stay |
72.5; 88.2 | — |
| PRIMARY Weight Gain |
13.6; 12.5 | — |
| PRIMARY Linear Growth |
1; 1 | — |
| PRIMARY Head Circumference Growth |
0.8; 0.8 | — |
| SECONDARY Days to Final Enteral Feed Volume |
12.4; 13.9 | — |
| SECONDARY Rates of Necrotizing Enterocolitis (NEC) |
1; 2 | — |
| SECONDARY Rates of Spontaneous Intestinal Perforation (SIP) |
0; 2 | — |
| SECONDARY Rates of Late-onset Sepsis |
4; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02573779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.