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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 24 Weeks to 29 Weeks |
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki) |
| Status | Recruiting |
| Started | March 4, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT07652684 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
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Papageorgiou General Hospital
Thessaloniki, Greece Recruiting
Study contacts
- Study coordinator: Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
- Email: mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
- Phone: +30 6932883161
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Continuing CPAP protection for extremely preterm babies to reduce BPD or death
This study tests whether keeping CPAP up to 34 weeks' PMA or for at least 2 more weeks, instead of weaning to a nasal cannula, lowers the chance of bronchopulmonary dysplasia or death by 36 weeks' PMA in babies born before 29 weeks gestation.
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Looking at tiny particles in cord blood of babies born before 28 weeks
The team will test whether extracellular vesicles in umbilical cord blood can help predict serious complications in babies born before 28 weeks of pregnancy.
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Long-term impact of BPD on parents and caregivers (BronQ Family)
This project will see how having a child who had bronchopulmonary dysplasia (BPD) affects parents' and caregivers' quality of life and family burden across several countries using an online questionnaire.
-
Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?
This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.
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Metformin treatment for premature infants with bronchopulmonary dysplasia
This study tests whether giving metformin to premature infants with bronchopulmonary dysplasia can reduce lung injury and help lungs grow.
-
Montelukast for critically ill premature infants developing bronchopulmonary dysplasia: pharmacokinetics, safety, and early efficacy
This study gives once-daily montelukast to critically ill premature infants developing bronchopulmonary dysplasia to test how the drug moves through the body, whether it is safe, and whether it helps breathing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.