High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preter… (NCT07307612) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
United States150 participantsStarted 2026-08-15
Plain-language 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).
Who can participate
Age range
1 Day – 3 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age ≤ 28 weeks of gestation
* Postnatal age \< 72 hours
Exclusion Criteria:
* Congenital malformations
* Chromosomal anomalies
* Terminal illness needing to limit or withhold support
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still in Phase 1/2 and hasn't started recruiting yet — what does that mean for how much is already known about the safety and effectiveness of high-energy human milk feeding in extremely premature babies, and should we wait to see earlier results before considering it?
2The trial focuses on the first two weeks after birth, which is a very narrow and critical window — if my baby is already past that point, or we're approaching it quickly, is there still time to realistically explore this as an option?
3The study is measuring lung function using something called impulse oscillometry — can you explain what that test involves for a premature infant, and what it would mean for my baby's care if the results show changes in pulmonary mechanics?
4Since this trial is specifically about reducing bronchopulmonary dysplasia through nutrition, how does this approach compare to the standard nutritional care my baby would receive in the NICU right now, and what would my baby potentially miss out on — or gain — by being in the trial versus standard treatment?
5Because the trial isn't recruiting yet, is there a way to be notified or pre-screened when it does open, and are there similar completed studies whose results we could look at now to help us decide if this direction makes sense for my baby?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of respiratory morbidity
Timeframe: 0 - 120 days
2
Non-invasive impulse oscillometry measurements of pulmonary mechanics