Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
Conditions
Keywords
Vitamin A, Preterm Infants, Bronchopulmonary Dysplasia, Randomized Controlled Trial, Neonatal Intensive Care
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.
Detailed description
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.
Interventions
DRUGVitamin A
Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.
Sponsors
Erhan Calisici
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This study was conducted as an open-label randomized controlled trial.
Intervention model description
Participants were assigned to one of two parallel groups: oral vitamin A supplementation or standard care.
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonary Dysplasia | 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. |
| Mortality | Up to 44 weeks postmenstrual age | All-cause mortality during hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | Up to 44 weeks postmenstrual age | Total duration of invasive mechanical ventilation in days. |
| Length of Hospital Stay | Up to 44 weeks postmenstrual age | Total duration of hospitalization from birth to discharge in days. |
| Necrotizing Enterocolitis | Up to 44 weeks postmenstrual age | Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria. |
| Retinopathy of Prematurity | Up to 44 weeks postmenstrual age | Incidence of retinopathy of prematurity diagnosed according to standard screening criteria. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORErhan Calisici, MD
Kocaeli City Hospital
Outcome results
None listed