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NCT02475434 · ClinicalTrials.gov registry record · NA
Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 210
- Enrollment target
NCT02475434: Completed NA study, sponsored by Baylor College of Medicine.
NCT02475434 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 210 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02475434, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint for the study is the difference in length of hospital stay (days) between the two groups from birth until discharge or removal from the study (due to transfer to non-study institution or death), whichever comes first.
Interventions
- DIETARY_SUPPLEMENT Cream Supplement group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2015-06-10 |
| Est. Completion | 2025-12-30 |
| Phase | NA |
What the finished NCT02475434 record still lists
NCT02475434 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Cream Supplement group is the first listed.
NCT02475434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02475434 about?
NCT02475434 is a clinical study titled "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 e...
What is the current status of trial NCT02475434?
This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2015-06-10. Estimated completion is 2025-12-30.
What interventions are being tested in trial NCT02475434?
The interventions under investigation include: Cream Supplement group (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02475434?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02475434's enrollment target sits among peer trials
210 490th of 2000 higher than 1,505 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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