CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
Cream Supplement groupdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02475434
NCT02475434N/ACompleted

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

Baylor College of Medicine·interventional·Posted Jun 18, 2015·Updated Jan 29, 2026

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

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 18, 2015
Enrollment StartJun 10, 2015
Primary CompletionJun 25, 2019
Study CompletionDec 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.0 years ago

Interventions

Cream Supplement groupdietary

Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.