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

NCT07577180 | Completed Phase 3

• 1 other identifier: VITA-BPD-2012
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchopulmonary Dysplasia (BPD); Prematurity; Very Low Birth Weight

Keywords

Vitamin A; Preterm Infants; Bronchopulmonary Dysplasia; Randomized Controlled Trial; Neonatal Intensive Care

Outcome Measures

Primary Outcomes (2)

• Bronchopulmonary Dysplasia

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

  At 36 weeks postmenstrual age

• Mortality

  All-cause mortality during hospitalization.

  Up to 44 weeks postmenstrual age

Secondary Outcomes (4)

• Duration of Mechanical Ventilation

  Up to 44 weeks postmenstrual age

• Length of Hospital Stay

  Up to 44 weeks postmenstrual age

• Necrotizing Enterocolitis

  Up to 44 weeks postmenstrual age

• Retinopathy of Prematurity

  Up to 44 weeks postmenstrual age

Study Arms (2)

Vitamin A Group

EXPERIMENTAL

Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care.

Drug: Vitamin A

Control Group

NO INTERVENTION

Preterm infants received standard neonatal care without vitamin A supplementation.

Interventions

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.

Also known as: Retinol

Vitamin A Group

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies
• Chromosomal abnormalities
• Severe perinatal asphyxia
• Inborn errors of metabolism
• Infants who died before initiation of enteral feeding

Sponsors & Collaborators

• Erhan Calisici: lead

Study Sites (1)

Kocaeli City Hospital

Köseköy, Kocaeli, 41060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Erhan Calisici, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label randomized controlled trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist, Neonatal Intensive Care Specialist

Model Details: Participants were assigned to one of two parallel groups: oral vitamin A supplementation or standard care.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)