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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: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT01534481 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 483 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)
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 |
What the finished NCT01534481 record still lists
NCT01534481 is an interventional study that assigns participants to a tested intervention. The registered 483 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Donor Milk is the first listed.
NCT01534481 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01534481's enrollment target sits among peer trials
483 792nd of 2000 higher than 1,209 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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