Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial

Abstract

Objective 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). Study design 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 beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). Result After the first interim analyses 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 analysis after 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 beractant group ( 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). Conclusions 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.

Evaluation of T-piece resuscitator in the delivery room management of pre-term neonates with respiratory distress syndrome in resource-limited settings: A pre-post intervention study

“…22 Though we had discontinued prophylactic SRT in our DRs preceding the present study, but a higher threshold of FiO 2 >40% for SRT was practiced in our unit for an ongoing study during the two epochs. 27 With rising pre-term births in LMICs, TPR use may have a potential of stabilizing surfactant consumption in busy perinatal centres.…”

Mortality and Morbidity in Premature Infants: An East and West Comparative Study

“…The higher incidence of sepsis causing neonatal deaths were consistent with two recent studies from India reporting up to 41% of deaths due to sepsis in VLBW infants. 20,21 Antenatal care practices may differ, including frequency of prenatal care visits, gestational age at maternal referral, and antibiotics administered to mothers with preterm rupture of membranes or preterm labor. Postnatal care practices differ as well, including empirical antibiotics chosen for early or late onset sepsis for preterm infants with risk factors, central line maintenance, and infection control prac-tices.…”

“…In addition, TCH patients also had higher odds of BPD (aOR ¼ 2.2, 95% CI: 1.15-3.21, p < 0.001) and moderate-to-severe BPD at 36 weeks' PMA in infants with less than 32 weeks' gestation (aOR ¼ 14.5 [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26], p < 0.001), longer length of hospitalization (adjusted mean difference [aMD] ¼ 31.3 days, 95% CI: 28.4-34.3, p < 0.001), higher discharge weight (aMD ¼ 1,102.9 g, 95% CI: 1,025.7-1,180; p < 0.001) and higher PMA at discharge (aMD ¼ 4.5 weeks, 95% CI: 4.1-4.9. p < 0.001) in the multivariable regression analysis. The incidence of grade 2 or more PVL, severe ROP, combined outcomes of death or BPD, and death or any adverse outcome were not significantly different between FH and TCH in the multivariate regression analysis controlling for the same covariates.…”