Effect of minimally invasive surfactant therapy on death or bronchopulmonary dysplasia in preterm infants
JAMA Jan 06, 2022
Dargaville PA, Kamlin COF, Orsini F, et al. - By conducting this randomized clinical trial, researchers investigated whether an improved survival without bronchopulmonary dysplasia (BPD) could be achieved with selective administration of surfactant via a thin catheter (minimally invasive surfactant therapy [MIST]) at a low oxygenation threshold, vs continuous positive airway pressure (CPAP) continuation, in preterm infants with respiratory distress syndrome supported with CPAP.
Study participants were 485 preterm infants with a gestational age of 25 to 28 weeks and respiratory distress syndrome who were supported with CPAP and required a fraction of inspired oxygen of 0.30 or greater within 6 hours of birth.
These infants were randomly assigned to the MIST group (n = 241) and were administered exogenous surfactant (200 mg/kg of poractant alfa) via a thin catheter or to the control group (n = 244) [a sham (control) treatment]; CPAP was continued thereafter in both groups unless specified intubation criteria were met.
In the MIST group and control group, occurrence of death or BPD was seen in 43.6% and 49.6% of infants, respectively, (risk difference [RD], −6.3% [95% CI, −14.2% to 1.6%]; relative risk [RR], 0.87 [95% CI, 0.74 to 1.03]; P = .10).
Incidence of death before 36 weeks’ postmenstrual age did not differ significantly between groups, however, the MIST group had lower incidence of BPD in survivors to 36 weeks’ postmenstrual age (37.3% vs 45.3% in the control group; RD, −7.8%; RR, 0.83).
In the MIST and control groups, serious adverse events developed in 10.3% and 11.1% of infants, respectively.
Overall, no statistically significant reduction in the likelihood of the composite outcome of death or bronchopulmonary dysplasia was achieved with surfactant administration via a thin catheter in this patient population.
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