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Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28+0 to
Ashadur Zamal1, Md Habibullah Sk1, Bijan Saha1
1Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, Kolkata, India.
Insights
Bovine lipid-extracted surfactant (BLES) and poractant alfa demonstrate comparable effectiveness in managing respiratory distress syndrome (RDS) in preterm infants using less invasive surfactant administration (LISA) in low- and middle-income countries (LMICs). BLES offers a more cost-effective treatment option for neonatal care.
Area of Science:
- Neonatal Medicine
- Pulmonology
- Pharmacoeconomics
Background:
- Respiratory distress syndrome (RDS) significantly contributes to neonatal morbidity and mortality, particularly in low- and middle-income countries (LMICs).
- The comparative effectiveness and cost-efficiency of bovine lipid-extracted surfactant (BLES) versus poractant alfa, administered via less invasive surfactant administration (LISA), have not been previously studied in LMICs.
Purpose of the Study:
- To compare the clinical outcomes of BLES and poractant alfa in preterm infants diagnosed with RDS and managed with LISA.
- To evaluate the cost-effectiveness of BLES compared to poractant alfa in resource-constrained neonatal intensive care settings.
Main Methods:
- A randomized controlled trial was conducted in an Indian level 3 neonatal intensive care unit.
- Preterm infants (28+0 to 34+6 weeks gestation) with RDS requiring non-invasive respiratory support and supplemental oxygen were randomized to receive either BLES (135 mg/kg) or poractant alfa (200 mg/kg) via LISA.
- The primary outcome was the need for intubation within 72 hours of life; secondary outcomes included clinical parameters and major morbidities.
Main Results:
- No statistically significant difference in the rate of intubation within 72 hours was observed between the BLES (13.5%) and poractant alfa (11.3%) groups (p=0.710).
- Clinical parameters such as FiO₂, SpO₂, heart rate, and mean airway pressure showed no significant differences between the groups post-administration.
- The average cost of surfactant per infant was significantly lower for BLES (INR 20,539) compared to poractant alfa (INR 29,677) (p < 0.001).
Conclusions:
- Bovine lipid-extracted surfactant (BLES) and poractant alfa exhibit similar clinical effectiveness for managing RDS in preterm infants using LISA in LMIC settings.
- BLES presents a cost-effective alternative to poractant alfa, offering significant savings in resource-constrained neonatal care environments without compromising clinical outcomes.
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+0 and 34+6 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.
