At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Cream Supplement group for Bronchopulmonary Dysplasia. Completed, enrolled 210 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.