Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial
2019
To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (
beractant; Survanta®, AbbVie, USA) for the treatment of
neonatal respiratory distress syndrome(RDS). We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or
beractant. Repeat dose, if required, was open-label
beractantin both the groups. The primary outcome was a composite of death or
bronchopulmonary dysplasia(BPD) at 36 weeks postmenstrual age (PMA).
Interimanalyses were done by an independent data and
safety monitoringboard (DSMB). After the first
interimanalyses on 5% enrolment, the “need for repeat dose(s) of surfactant” was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second
interim analysisafter 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to
beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and
beractantgroup (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7–3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5–23.3; p < 0.001). Goat lung surfactant was less efficacious than
beractant(Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.
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