Minimal Invasive Surfactant Administration to Treat Neonatal Respiratory Distress Syndrome: a Multicenter Clinical Study in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Incidence of bronchopulmonary dysplasia (BPD)
研究概览
简要总结
BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and mechanical ventilation made millions of preterm infants survived in neonatal intensive care unit (NICU). Endotracheal intubation surfactant administration is related to invasive intubation and short periods of positive pressure ventilation and implies the risk of lung injury. Continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) with surfactant but without intubation may work synergistically. This randomized trial investigated a minimal invasive surfactant administration (MISA). To test the hypothesis that MISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks' gestational age in very low birth weight infants.
DESIGN, SETTING, AND PARTICIPANTS The Minimal Invasive Surfactant Administration (MISA) was a multicenter, randomized, clinical, parallel-group study conducted between July 1st, 2017, and November 30, 2018, in 8 level III neonatal intensive care units in Beijing, Tianjin, and Hebei province, China. The final follow-up date was March 30, 2019. Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. In an intention-to-treat design, infants were randomly assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) either via a 5Fr nasogastric tube during CPAP/NIPPV-assisted spontaneous breathing (minimal invasive surfactant administration group, MISA group) or after conventional endotracheal intubation during mechanical ventilation (endotracheal intubation surfactant administration group, EISA group).
INTERVENTION MISA via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants born before 32 weeks gestational age
- •spontaneously breathing receiving continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) without intubation
- •clinical diagnosis of respiratory distress syndrome.
排除标准
- •with obvious malformations
- •with asphyxia requiring intubation during resuscitation
- •need endotracheal intubation or mechanical ventilation before surfactant administration.
研究组 & 干预措施
MISA group
minimal invasive surfactant administration group
干预措施: Minimal Invasive surfactant administration (Procedure)
EISA group
conventional treatment: endotracheal intubation surfactant administration group
结局指标
主要结局
Incidence of bronchopulmonary dysplasia (BPD)
时间窗: At 36 weeks'gestational age
Number of very low birth weight preterm infants with BPD
次要结局
- Incidence of major complications(Through study completion and up to corrected three months)
研究者
Han Tongyan
Vice Director of Pediatrics Department, Principal Investigator, Clinical Associated Professor
Peking University Third Hospital