Neonatal
acute respiratory distress syndrome (NARDS) reflects
pulmonary surfactant dysfunction, and the usage of bovine
surfactant (
Calsurf) supplement may therefore be beneficial. To determine whether bovine
surfactant given in NARDS can improve oxygenation and survival rate, we conducted a multicenter, randomized trial between January 2018 and June 2019, and we compared
Calsurf treatment to controls in neonates with
pneumonia accompanied by NARDS. Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations were excluded. Primary outcomes were oxygenation index (OI) after
Calsurf administration, and secondary outcomes were mortality, and duration of
ventilator and
oxygen between the two groups, and also other morbidities. Cumulatively, 328 neonates were recruited and analyzed, 162 in the control group, and 166 in the
Calsurf group. The results shows that OI in the
Calsurf group were significantly lower than that in the control group at 4 h (7.2 ± 2.7 and 11.4 ± 9.1, P = 0.001); similarly, OI in the
Calsurf group were significantly lower than in the control group at 12 h ( 7.5 ± 3.1 and 11.2 ± 9.2, P = 0.001). Mortality and duration of
ventilator support or
oxygen use between the two groups were not significantly different.Conclusion:
Calsurf acutely improved OI immediately after administration in
pneumonia-induced NARDS; although, we observed no significant decrease in mortality, duration of
ventilator or
oxygen, or major morbidity. What is known: • The definition proposed as the Monteux criteria for neonatal
acute respiratory distress syndrome (NARDS). •
Surfactant acutely improved oxygenation and significantly decreased mortality in children and adolescents with
acute lung injury. What is new: • This is the first large randomized controlled trail to study on
surfactant treatment of neonates with acute
respiratory distress syndromes. •
Surfactant acutely improved oxygenation immediately after administration in
pneumonia-induced NARDS at a gestational age beyond 34 weeks.