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Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28

Pediatric pulmonology2025-09-09PubMed
Total: 79.5Innovation: 7Impact: 0Rigor: 0Citation: 0

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