Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28 to 34 Week) With Respiratory Distress Syndrome: A Randomized Controlled Trial.

BACKGROUND

Respiratory distress syndrome (RDS) is a leading cause of neonatal morbidity and mortality in low- and middle-income countries (LMICs). The feasibility and effectiveness of bovine versus porcine surfactants via less invasive surfactant administration (LISA) remain unstudied in LMICs. We compared clinical outcomes and cost-effectiveness of BLES versus poractant alfa in preterm infants with RDS managed with LISA.

METHODS

This randomized controlled trial was conducted in a level 3 neonatal intensive care unit in India. Eligible preterm infants born between 28 and 34 weeks of gestation who developed RDS requiring Noninvasive respiratory support and supplemental oxygen (FiO₂ ≥ 30%) within 6 h of birth were enrolled. Infants were randomly assigned (1:1) to receive either BLES 135 mg/kg (5 mL/kg) or poractant alfa 200 mg/kg (2.5 mL/kg) via the LISA technique. The primary outcome was need for intubation within 72 h of life.

RESULT

From Jan 24, 2024 to Mar 15, 2025, 282 infants were randomized to BLES or poractant alfa (n = 141 each). Intubation within 72 h occurred in 19 (13.5%) infants in the BLES group and 16 (11.3%) in the poractant alfa group (p = 0.710). There were no statistically significant differences in FiO₂, SpO₂, heart rate, or mean airway pressure at any time point before or after surfactant administration between the two groups. No significant differences were observed in major morbidities or mortality. The average cost of surfactant per infant was significantly lower with BLES (INR 20,539 vs 29,677; p < 0.001).

CONCLUSION

In LMIC settings, BLES and poractant alfa showed similar effectiveness for RDS management via LISA, with no difference in clinical outcomes. BLES provides a cost-effective alternative in resource-constrained neonatal care.