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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 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 210 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02475434
The ClinicalTrials.gov registry entry for NCT02475434 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cream Supplement group is the first listed.
NCT02475434 reports 0 study locations.
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.
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