Rong Zhihui, Mo Luxia, Pan Rui, Zhu Xiaofang, Cheng Hongbin, Li Maojun, Yan Lubiao, Lang Yujie, Zhu Xiaoshan, Chen Liping, Xia Shiwen, Han Jun, Chang Liwen
Department of Neonatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Department of Neonatology, Wuhan Maternal and Child Healthcare Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Eur J Pediatr. 2021 Apr;180(4):1107-1115. doi: 10.1007/s00431-020-03821-2. Epub 2020 Oct 21.
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.
新生儿急性呼吸窘迫综合征（NARDS）反映了肺表面活性物质功能障碍，因此使用牛肺表面活性剂（Calsurf）补充剂可能有益。为了确定在NARDS中给予牛肺表面活性剂是否能改善氧合和存活率，我们在2018年1月至2019年6月期间进行了一项多中心随机试验，比较了Calsurf治疗与伴有NARDS的肺炎新生儿对照组的情况。纳入符合NARDS蒙特勒标准定义的新生儿，排除先天性心肺畸形的新生儿。主要结局是给予Calsurf后氧合指数（OI），次要结局是死亡率、两组之间呼吸机使用时间和吸氧时间，以及其他发病率。累计招募并分析了328例新生儿，对照组162例，Calsurf组166例。结果显示，Calsurf组在4小时时的OI显著低于对照组（7.2±2.7和11.4±9.1，P = 0.001）；同样，Calsurf组在12小时时的OI也显著低于对照组（7.5±3.1和11.2±9.2，P = 0.001）。两组之间的死亡率、呼吸机支持时间或吸氧时间无显著差异。结论：在肺炎诱发的NARDS中，Calsurf给药后可立即急性改善OI；尽管如此，我们未观察到死亡率、呼吸机或吸氧时间或主要发病率有显著降低。已知信息：• 作为新生儿急性呼吸窘迫综合征（NARDS）的蒙特勒标准提出的定义。• 表面活性物质可急性改善急性肺损伤儿童和青少年的氧合并显著降低死亡率。新发现：• 这是第一项关于表面活性物质治疗新生儿急性呼吸窘迫综合征的大型随机对照试验。• 在孕周超过34周的肺炎诱发的NARDS中，表面活性物质给药后可立即急性改善氧合。
