Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the size of PDA
研究概览
简要总结
In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.
详细描述
To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.
Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestation age less than or equal to 32 weeks
- •PS is needed
排除标准
- •main congenital abnormalities
- •parents' refusal or quit
研究组 & 干预措施
PS is stopped when the pressure is equal between bPDA and aPDA
PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound
干预措施: PS is stopped when the pressure is equal between bPDA and aPDA. (Drug)
PS is given according to the 2019 European RDS management guideline
PS is given according to the 2019 European RDS management guideline
干预措施: PS is given according to the 2019 European RDS management guideline (Drug)
结局指标
主要结局
the size of PDA
时间窗: within 7 days after birth
the size of PDA is zero
BPD and/or death
时间窗: at 36 week's gestational age
the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age
次要结局
未报告次要终点
研究者
Chen Long,MD
Director
Children's Hospital of Chongqing Medical University