New findings from randomised clinical trial - prophylactic oropharyngeal surfactant for preterm newborns at birth

Congratulations to Dr Marie Galligan, Professor Colm O'Donnell, Dr Madeleine Murphy and all involved in research assessing whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure.

The research posed the question, 'Does giving prophylactic oropharyngeal surfactant at birth in addition to continuous positive airway pressure (CPAP) to preterm newborns result in fewer newborns being intubated and receiving ventilation for respiratory failure within 120 hours of birth?'.

In this randomised clinical trial of 251 newborns born before 29 weeks of gestation, giving prophylactic oropharyngeal surfactant at birth did not result in fewer newborns being intubated for respiratory failure within 120 hours of birth.

This unblinded, parallel-group randomised clinical trial (Prophylactic Oropharyngeal Surfactant for Preterm Infants [POPART]) was conducted from December 17, 2017, to September 11, 2020, at 9 tertiary neonatal intensive care units in 6 European countries. Newborns born before 29 weeks of gestation without severe congenital anomalies, for whom intensive care was planned, were eligible for inclusion. The data were analyzed from July 27, 2022, to June 20, 2023.

Among 251 participants (mean [SD] GA, 26 [1.5] weeks) who were well matched at study entry, 126 (69 [54.8%] male) with a mean (SD) birth weight of 858 (261) grams were assigned to the oropharyngeal surfactant group, and 125 (63 [50.4%] male) with a mean (SD) birth weight of 829 (253) grams were assigned to the control group. The proportion of newborns intubated within 120 hours was not different between the groups (80 [63.5%) in the oropharyngeal surfactant group and 81 [64.8%] in the control group; relative risk, 0.98 [95% CI, 0.81-1.18]). More newborns assigned to the oropharyngeal surfactant group were diagnosed with and treated for pneumothorax (21 [16.6%] vs 8 [6.4%]; P = .04).

This randomised clinical trial found that administration of prophylactic oropharyngeal surfactant to newborns born before 29 weeks’ GA did not reduce the rate of intubation in the first 120 hours of life. These findings suggest that administration of surfactant into the oropharynx immediately after birth in addition to CPAP should not be routinely used.

Read the full investigation on the JAMA Pediatrics site here.