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NCT03001479 · ClinicalTrials.gov registry record · NA
Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein
A NA study, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT03001479: Completed NA study, sponsored by St. Louis University.
NCT03001479 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03001479, a NA study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study Summary
Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the addition of fortifiers to their milk in order to achieve sufficient levels of calories, vitamins, and minerals for adequate growth. We are currently using a liquid human milk fortifier which does not provide sufficient protein intake, requiring addition of a liquid protein supplement. A new product has been released which provides sufficient protein in the liquid HMF, without the acidification seen in previous products. This is a prospective, randomized noninferiority study comparing the safety and efficacy of the new HMF with additional protein to our current standard of adding additional protein supplementation on top of the HMF.
Primary Outcome
(grams) in first 30 days on HMF
Interventions
- DIETARY_SUPPLEMENT Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2023-05-01 |
| Phase | NA |
What the finished NCT03001479 record still lists
NCT03001479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid is the first listed.
NCT03001479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03001479 about?
NCT03001479 is a clinical study titled "Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein". Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the addition of fortifiers to their milk in order to achieve sufficient levels of calories, vitamins, and minerals f...
What is the current status of trial NCT03001479?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2017-03-13. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT03001479?
The interventions under investigation include: Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03001479?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03001479's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 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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