Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 24 Weeks to 29 Weeks

Enteral DHA and ARA Supplementation for Very Preterm Infants with BPD Risk

Official title: Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)

Run by Aristotle University Of Thessaloniki · NCT07652684 · Data updated 2026-11-12

This study tests whether giving a specific mix of DHA and ARA through feeding helps prevent bronchopulmonary dysplasia in extremely and very preterm babies.

More Bronchopulmonary Dysplasia (BPD) trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages24 Weeks to 29 Weeks
SexAll
Enrollment74 (estimated)
SponsorAristotle University Of Thessaloniki
Academic / other
Locations1 site (Thessaloniki)
StatusRecruiting
StartedMarch 4, 2025
Main results expectedNovember 30, 2026
Study endsMarch 1, 2027
Registry record updatedJune 17, 2026
Trial IDNCT07652684 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants born at ≤29 weeks gestation at Papageorgiou Hospital/NICU in Thessaloniki whose parents provide consent within 48 hours of birth.

Probably not a fit

Infants with congenital anomalies, chromosomal abnormalities, or critical illness with short life expectancy, or those who do not receive the supplementation per protocol, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares enteral supplementation with a 2:1 ratio of ARA to DHA to standard care in infants born at 24–29 weeks gestation. Beginning within 72 hours of birth, supplementation continues until 36 weeks postmenstrual age. Infants eligible are those born at the Papageorgiou Hospital/NICU in Thessaloniki and without major congenital issues or life expectancy concerns, with parental consent obtained soon after birth. Outcomes focus on development of bronchopulmonary dysplasia and related respiratory health, using a parallel-group design.

Why it matters

Potential benefit: If successful, the supplementation could reduce the risk or severity of bronchopulmonary dysplasia in very preterm infants.

How similar studies have gone: Previous studies in preterm infants have explored omega-3 and omega-6 fatty acids, but this specific 2:1 ARA:DHA supplementation approach is being tested for its potential to affect BPD outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Infants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.

Exclusion Criteria:

Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.

Study participation requires written informed parental consent within 48h after birth.

Where it's running

  • Papageorgiou General Hospital
    Thessaloniki, Greece
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.