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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 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 78 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03001479
The ClinicalTrials.gov registry entry for NCT03001479 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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