Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
brief summary
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.
detailed description
The primary hypothesis of the study is that infants who receive an exclusive HM-based diet with the addition of a HM-derived cream caloric (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 study design is a randomized controlled trial in preterm infants (birth weight 500-1250g) comparing the use of a human milk cream supplement added to an exclusive HM-based diet (Cream group) to an exclusive HM-based diet without the use of a cream supplement (Control group). Each study group will use mother's own milk, donor HM if needed (donor HM should be obtained from a Human Milk Banking Association of North America (HMBANA) or Prolacta milk bank that uses Holder method pasteurization and does not homogenize the milk) and a donor human milk-derived fortifier (Prolact+ H2MF®) according to the study feeding protocol. Feeding will be done by protocol in which fortification will begin when the baby is receiving 60 mL/kg/day of enteral nutrition. The randomization will be performed in blocks (block size to remain blinded) without the use of stratification variables except for study site. While blinding of study groups is always desirable in randomized studies, because of the nature of the interventions and the varying methods by which the nutrition is prepared and delivered in different units, this will not be possible for this study.
Sample Size:
The number of infants to be included in this study is based on the primary endpoint of a reduction in the length of hospital stay in days by 12.1 days with a standard deviation of 31 days. With a two-tailed 5% significance level and 80% power, a sample size of 210 (n=105 per group) is needed to demonstrate a difference of this magnitude between the 2 study groups.
Study Duration:
All study infants will be followed until discharge or transfer from the medical institution or death (hospital stay is an expected average of 10 weeks). Infants will be transitioned completely off an exclusive HM-based diet no earlier than 34 weeks PMA, however, infants will be followed until hospital discharge (total of an estimated average of 10 weeks) to collect anthropometric and study outcome data.
Study Population:
Each study subject must meet all of the indicated inclusion criteria and none of the exclusion criteria.
official title
Post-Discharge Evaluation of Human Milk Cream Study Infants at 18 to 24 Month CGA: A Randomized Trial of the Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants