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NCT04325308 · ClinicalTrials.gov registry record · NA
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
A NA study of Microbial Colonization and Prematurity; Extreme, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04325308: Active NA study of Microbial Colonization and Prematurity; Extreme, sponsored by University of Alabama at Birmingham.
NCT04325308 is a NA study of Microbial Colonization and Prematurity; Extreme that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04325308, a NA study of Microbial Colonization and Prematurity; Extreme, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
Primary Outcome
Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.
Conditions Studied
Interventions
- PROCEDURE Protein-enriched human milk diet
- PROCEDURE Usual human milk diet
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What the registry record for NCT04325308 still lists
NCT04325308 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Microbial Colonization appearing as the primary indexed condition, and to 2 interventions - of which Protein-enriched human milk diet is the first listed.
NCT04325308 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04325308 about?
NCT04325308 is a clinical study titled "Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk". The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected ...
What is the current status of trial NCT04325308?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-13. Estimated completion is 2026-09-30.
What conditions does trial NCT04325308 study?
This clinical trial studies the following conditions: Microbial Colonization, Prematurity; Extreme, Growth Failure, Breast Milk Expression, Feeding Disorder Neonatal.
What interventions are being tested in trial NCT04325308?
The interventions under investigation include: Protein-enriched human milk diet (PROCEDURE), Usual human milk diet (PROCEDURE).
Who is sponsoring clinical trial NCT04325308?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04325308 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 Microbial Colonization
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 NCT04325308's enrollment target sits among peer trials
150 8th of 20 higher than 12 of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization 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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