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NCT07307612 · ClinicalTrials.gov registry record · Phase 1
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
NCT07307612: Clinical Trial Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT07307612 is a Phase 1 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07307612, a Phase 1 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
Study Summary
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
Primary Outcome
A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula \>2 L/min, CPAP, or non-invasive positive pressure ventil
Interventions
- DIETARY_SUPPLEMENT High-energy group
- OTHER Standard-energy group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-08-15 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 1 |
What is known before NCT07307612 opens enrollment
NCT07307612 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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 2 interventions - of which High-energy group is the first listed.
NCT07307612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07307612 about?
NCT07307612 is a clinical study titled "High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants". This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestati...
What is the current status of trial NCT07307612?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2026-08-15. Estimated completion is 2029-07-31.
What interventions are being tested in trial NCT07307612?
The interventions under investigation include: High-energy group (DIETARY_SUPPLEMENT), Standard-energy group (OTHER).
Who is sponsoring clinical trial NCT07307612?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07307612's enrollment target sits among peer trials
150 363rd of 2000 higher than 1,620 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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