Project Details

Budesonide and surfactant therapy versus surfactant alone to reduce lung disease in preterm infants

James Sotiropoulos, MD, BSc, BMed

Summary

BACKGROUND: Bronchopulmonary dysplasia (BPD), the chronic lung disease of prematurity, is the leading cause of long-term morbidity in very preterm infants born before 32 weeks’ gestation (more than 2 months early). Combining surfactant therapy (a routine, safe medicine given into the lungs to treat preterm respiratory distress syndrome) with an anti-inflammatory corticosteroid has been proposed to prevent BPD in preterm infants. GAP: 1) Is surfactant plus corticosteroid effective in preventing adverse outcomes in very preterm infants? and 2) are there differential effects across subgroups? HYPOTHESIS: 1) Surfactant plus corticosteroid will reduce the rate of death or BPD in very preterm infants, compared to surfactant alone. 2) Surfactant plus corticosteroid will provide additional benefit to infants with more severe lung disease (higher oxygen requirements) prior to therapy administration, at lower gestational age, without antenatal steroid coverage, and with lower birthweight for gestational age. METHODS: We will conduct an individual participant data meta-analysis (IPD-MA, synthesis of raw line-by-line data) of RCTs in very preterm infants comparing surfactant plus corticosteroid with surfactant alone. The primary outcome will be death or BPD at 36 weeks’ postmenstrual age (PMA). We will adhere to ‘gold- standard’ analysis strategies and perform rigorous data quality, risk of bias and integrity checks. RESULTS: Pending. IMPACT: Interventions to decrease rates of BPD are urgently required. If effective, surfactant plus corticosteroid would be a low-cost addition to standard care to reduce BPD and increase disability-free survival. Website Link: https://www.linkedin.com/in/jamessotiropoulos/