Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01534481 · ClinicalTrials.gov registry record · Phase 3
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 483
- Enrollment target
NCT01534481 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 483 participants.
The verdict
NCT01534481, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 483 participants
- Enrollment target
Study Summary
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be randomized to receive donor breast milk or formula during their hospital stay. Infant's will be followed until they reach 22-26 months of age.
Interventions
- BIOLOGICAL Donor Milk
- DIETARY_SUPPLEMENT Preterm Formula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 483 participants |
| Start Date | 2012-08 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01534481
The ClinicalTrials.gov registry entry for NCT01534481 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 483 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Donor Milk is the first listed.
NCT01534481 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01534481 about?
NCT01534481 is a clinical study titled "Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants". The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be ...
What is the current status of trial NCT01534481?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 483 participants. The study started on 2012-08. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT01534481?
The interventions under investigation include: Donor Milk (BIOLOGICAL), Preterm Formula (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01534481?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.