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NCT Number: NCT07577180

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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury Very Low Birth Weight

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kocaeli City Hospital

Köseköy, Kocaeli, 41060, Turkey (Türkiye)

About this study

Bronchopulmonary dysplasia (BPD) is a chronic lung disease commonly observed in very low birth weight (VLBW) preterm infants and is associated with significant morbidity and mortality. Vitamin A plays a critical role in lung growth, epithelial differentiation, and repair processes. Previous studies have suggested that vitamin A supplementation may reduce the incidence of BPD, although the optimal route and regimen remain uncertain.

This study was designed as a randomized controlled trial to assess the efficacy of oral high-dose vitamin A supplementation in preventing BPD in preterm infants. Infants with a gestational age of ≤32 weeks and birth weight <1250 g were enrolled and randomly assigned to receive either prophylactic oral vitamin A supplementation or standard neonatal care.

The primary outcome was the incidence of BPD, defined according to standard clinical criteria. Secondary outcomes included mortality, duration of respiratory support, and other neonatal complications.

The results of this study may contribute to the existing evidence on vitamin A supplementation and support the development of accessible and non-invasive preventive strategies for BPD in preterm infants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A

Drug

Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.

Other names: Retinol

Primary outcomes

  1. Bronchopulmonary Dysplasia

    Time frame: At 36 weeks postmenstrual age

    Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.

  2. Mortality

    Time frame: Up to 44 weeks postmenstrual age

    All-cause mortality during hospitalization.

Secondary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Up to 44 weeks postmenstrual age

    Total duration of invasive mechanical ventilation in days.

  2. Length of Hospital Stay

    Time frame: Up to 44 weeks postmenstrual age

    Total duration of hospitalization from birth to discharge in days.

  3. Necrotizing Enterocolitis

    Time frame: Up to 44 weeks postmenstrual age

    Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.

  4. Retinopathy of Prematurity

    Time frame: Up to 44 weeks postmenstrual age

    Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.

Sponsors and collaborators

Lead sponsor

Erhan Calisici

Other Gov

Registry information

Official study title

Effect of Weekly High-Dose Oral Vitamin A Supplementation on Bronchopulmonary Dysplasia in Very Low Birth Weight Preterm Infants: A Randomized Controlled Trial

Acronym: VITA-BPD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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