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NCT01991613 · ClinicalTrials.gov registry record · Phase 2
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
A Phase 2 study of Growth in Premature Infants, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01991613: Completed Phase 2 study of Growth in Premature Infants, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01991613 is a Phase 2 study of Growth in Premature Infants that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991613, a Phase 2 study of Growth in Premature Infants, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.
Primary Outcome
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT liquid protein supplement
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01991613 record still lists
NCT01991613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Growth in Premature Infants appearing as the primary indexed condition, and to 1 intervention - of which liquid protein supplement is the first listed.
NCT01991613 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01991613 about?
NCT01991613 is a clinical study titled "Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants". We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protei...
What is the current status of trial NCT01991613?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2013-12. Estimated completion is 2015-06.
What conditions does trial NCT01991613 study?
This clinical trial studies the following conditions: Growth in Premature Infants.
What interventions are being tested in trial NCT01991613?
The interventions under investigation include: liquid protein supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01991613?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01991613 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01991613's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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