CompletedPhase 3

Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants

Turkey (Türkiye)209 participantsStarted 2012-03-01

Plain-language summary

Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an increased risk of BPD. This study aimed to evaluate the effect of prophylactic oral high-dose vitamin A supplementation on the incidence of BPD in preterm infants with a gestational age ≤32 weeks and birth weight \<1250 g. In this randomized controlled trial, preterm infants were assigned to receive either oral vitamin A supplementation or standard care. The primary outcome was the development of BPD. Secondary outcomes included mortality and other neonatal morbidities. The findings of this study may provide evidence regarding the effectiveness of oral vitamin A supplementation as a simple and accessible strategy to reduce the risk of BPD in preterm infants.

Who can participate

Age range

0 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: * Preterm infants with gestational age ≤32 weeks * Birth weight ≤1250 grams * Admitted to the neonatal intensive care unit * Initiated enteral feeding within the first days of life Exclusion Criteria: * Major congenital anomalies * Chromosomal abnormalities * Severe perinatal asphyxia * Inborn errors of metabolism * Infants who died before initiation of enteral feeding

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.

1Since this Phase 3 trial studying oral vitamin A supplementation for BPD prevention in premature babies has already completed, has the results data been published yet, and what did it show about whether vitamin A actually reduced BPD rates or mortality in very low birth weight infants?
2Given that this trial used oral vitamin A rather than the injected form that's been studied before, can you explain whether the oral route is considered as effective or safe for my premature baby, and does the completed trial data change how you'd approach vitamin A supplementation in our situation?
3Since the trial is finished and not enrolling, is oral vitamin A supplementation something you would consider as part of my baby's current care plan based on what's known from this study and other evidence?
4Because BPD and mortality were both measured as primary outcomes in this trial, what does the existing evidence — including this study — suggest about the overall benefit-to-risk balance of vitamin A supplementation for a very premature or very low birth weight baby like mine?
5Are there other completed or ongoing studies, or standard-of-care approaches, that you think offer better-established options for reducing my baby's risk of BPD compared to what this trial was investigating?

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

Bronchopulmonary Dysplasia

Timeframe: At 36 weeks postmenstrual age

Mortality

Timeframe: Up to 44 weeks postmenstrual age

Trial details

NCT IDNCT07577180

SponsorErhan Calisici

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-03-01

View on ClinicalTrials.gov More Bronchopulmonary Dysplasia (BPD) trials