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Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care practice. The investigators hypothesize that infants who receive an exclusive human milk (HM)-based diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a shorter length of initial hospital stay compared to infants receiving the standard regimen of an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of the cream caloric supplement will be greater in the subgroup of infants who develop BPD so the relationship will be evaluated between Cream Supplement study group and postmenstrual age (PMA) at discharge and the incidence of BPD. Investigators will also evaluate the post-hospital discharge growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA of the infants 500-1250 grams BW who received an exclusive human milk diet including cream supplement or control in the NICU.
Details
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 210 |
| Start date | Wed Jun 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Bronchopulmonary Dysplasia
Interventions
- Cream Supplement group
Countries
Austria, United States