Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28
Summary
In a single-center RCT in India (n=282), BLES delivered via LISA was clinically equivalent to poractant alfa for preterm RDS, with similar intubation rates and morbidities. Drug cost per infant was substantially lower with BLES, supporting a cost-effective alternative in resource-limited settings.
Key Findings
- No difference in 72-hour intubation (13.5% BLES vs 11.3% poractant alfa; p=0.710).
- Physiologic parameters (FiO2, SpO2, HR, MAP) and major morbidities/mortality were similar across groups.
- Drug cost per infant was significantly lower with BLES (INR 20,539 vs 29,677; p<0.001).
Clinical Implications
BLES can be adopted as a lower-cost surfactant option without compromising outcomes when using LISA in preterm RDS, aiding scale-up of non-invasive respiratory care in LMIC NICUs.
Why It Matters
Provides robust comparative and cost-effectiveness evidence for surfactant choice via LISA in LMICs, potentially shifting formulary and procurement policies.
Limitations
- Single-center, open-label design may limit generalizability and introduce performance bias.
- Eligibility details (e.g., gestational age completion criteria) and blinding not fully described in abstract.
Future Directions
Multicenter, blinded, non-inferiority trials powered for clinically important outcomes (BPD, mortality) and full cost-utility analyses across diverse LMICs.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial providing highest level of comparative effectiveness evidence.
- Study Design
- OTHER