Zamal Ashadur, Sk Md Habibullah, Saha Bijan, Hazra Avijit
Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, Kolkata, India.
Department of Pharmacology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, Kolkata, India.
Pediatr Pulmonol. 2025 Sep;60(9):e71281. doi: 10.1002/ppul.71281.
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.
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.
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).
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.
呼吸窘迫综合征（RDS）是低收入和中等收入国家（LMICs）新生儿发病和死亡的主要原因。在LMICs中，通过微创表面活性剂给药（LISA）使用牛肺表面活性剂与猪肺表面活性剂的可行性和有效性尚未得到研究。我们比较了在接受LISA治疗的RDS早产儿中，牛肺表面活性剂提取物（BLES）与固尔苏的临床结局和成本效益。
这项随机对照试验在印度一家三级新生儿重症监护病房进行。纳入在妊娠28至34周之间出生、出生后6小时内发生RDS且需要无创呼吸支持和补充氧气（FiO₂≥30%）的符合条件的早产儿。婴儿通过LISA技术随机分配（1:1）接受BLES 135mg/kg（5mL/kg）或固尔苏200mg/kg（2.5mL/kg）。主要结局是出生后72小时内是否需要插管。
从2024年1月24日至2025年3月15日，282名婴儿被随机分配至BLES组或固尔苏组（每组n = 141）。BLES组19名（13.5%）婴儿在72小时内进行了插管，固尔苏组16名（11.3%）（p = 0.710）。两组在表面活性剂给药前后的任何时间点，FiO₂、SpO₂、心率或平均气道压力均无统计学显著差异。在主要发病率或死亡率方面未观察到显著差异。BLES治疗每名婴儿表面活性剂的平均成本显著更低（20,539印度卢比 vs 29,677印度卢比；p < 0.001）。
在LMICs环境中，BLES和固尔苏通过LISA治疗RDS显示出相似的有效性，临床结局无差异。在资源有限的新生儿护理中，BLES提供了一种具有成本效益的替代方案。
