Analysis of the effectiveness of pulmonary surfactant in the treatment of moderate and severe acute respiratory distress syndrome in infants and toddlers —a multicenter prospective study

Background: To determine the effectiveness of exogenous pulmonary surfactant (PS) on moderate or severe pediatric acute respiratory distress syndrome (PARDS) in infants and toddlers who need invasive mechanical ventilation support. Methods We conducted a multicenter prospective non-randomized control study in 14 tertiary pediatric intensive care units (PICUs) across China from 2016.12.1 to 2021.12.1. Infants and toddlers aged from 29 d to 3 years old with moderate or severe PARDS who needed invasive mechanical ventilation support were included and divided into experimental and controlled groups. In the experimental group, PS with a single dose of 140 mg was used after PARDS onset and it would be used once to thrice with an interval of 8 h according to the improvement of oxygenation index (OI). Patients in both groups received standard care. Results 101 patients were enrolled, 34 in PS group, 67 in control group. Demographic and baseline clinical data have no statistic differences. Mortality in the PS group is significantly lower (5.9%, 2/34 vs. 31.3%, 21/67, P = 0.004). The OI decrease within 24 hours in patients who use PS thrice is significantly faster than that in the control group [5.9 (2.53,12.73) vs. 2.6 (-2.2, 6.2), P = 0.048]. Subgroup analysis shows that OI improvement within 24 h (0.32 ± 0.21 vs. 0.02 ± 0.45, t = 2.08, P = 0.046) and 72 h [0.37 (0.17, 0.56) vs. 0.03 (-0.31, 0.40), z=-1.885, P = 0.059]is greater in PS-3 group compared to dead patients in control group. Conclusions Exogenous PS delivery may improve the pulmonary oxygenation in the acute phase of moderate or severe PARDS among infants and toddlers, thereby further decrease mortality. PS is expensive and should be used properly. Further study is needed to verify the effectiveness of PS in treating PARDS and identify the reasonable administration time and dosage. Trial registration: The research was registered in Chinese Clinical Trial Registry website (Registration Number: ChiCTR-ONC-16009213, 17/09/2016).