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NCT05525585 · ClinicalTrials.gov registry record · NA
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
A NA study of Prematurity and Enteral Feeding Intolerance, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05525585: Active NA study of Prematurity and Enteral Feeding Intolerance, sponsored by University of Alabama at Birmingham.
NCT05525585 is a NA study of Prematurity and Enteral Feeding Intolerance that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants, below the 207-participant average among 21 other Prematurity trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05525585, a NA study of Prematurity and Enteral Feeding Intolerance, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
Primary Outcome
Estimated by air displacement plethysmography
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Early HMF
- DIETARY_SUPPLEMENT Delayed HMF
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT05525585 still lists
NCT05525585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 207-participant average among 21 other Prematurity trials with a reported enrollment target (61% lower).
The record links to 3 conditions, with Prematurity appearing as the primary indexed condition, and to 2 interventions - of which Early HMF is the first listed.
NCT05525585 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05525585 about?
NCT05525585 is a clinical study titled "Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants". In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-fo...
What is the current status of trial NCT05525585?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-11-17. Estimated completion is 2026-05.
What conditions does trial NCT05525585 study?
This clinical trial studies the following conditions: Prematurity, Enteral Feeding Intolerance, Light-For-Dates.
What interventions are being tested in trial NCT05525585?
The interventions under investigation include: Early HMF (DIETARY_SUPPLEMENT), Delayed HMF (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05525585?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05525585 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prematurity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05525585's enrollment target sits among peer trials
80 13th of 21 higher than 9 of 21 other Prematurity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prematurity 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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