Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- bronchopulmonary dysplasia(BPD)
研究概览
简要总结
In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.
In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.
详细描述
To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth.
According to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility requirements for neonates were as follows:
- •The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth
- •The neonates will be diagnosed with NRDS or NARDS
- •The neonates will be at least administrated one dose of surfactant
排除标准
- •one of the following criteria will be needed
- •major congenital anomalies
- •chromosomal abnormalities
- •upper respiratory tract abnormalities
研究组 & 干预措施
one dose of surfactant
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
干预措施: one dose of surfactant replacement (Drug)
two and more doses of surfactant
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant
干预措施: two and more doses of surfactant replacement (Drug)
结局指标
主要结局
bronchopulmonary dysplasia(BPD)
时间窗: at 36 weeks' gestational age or before discharge from hospital
the preterm infants will be diagnosed with BPD
death
时间窗: at 36 weeks' gestational age or before discharge from hospital
the preterm infants die
BPD and/or death
时间窗: at 36 weeks' gestational age or before discharge from hospital
the preterm infants will be diagnosed with BPD and/or death
the predictive powers of one dose of surfactant to diagnose NRDS
时间窗: seven days after birth
the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
the predictive powers of two and more doses of surfactant to diagnose NARDS
时间窗: seven days after birth
the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS
次要结局
- late-onset sepsis(LOS)(at 36 weeks' gestational age or before discharge from hospital)
- periventricular leukomalacia(PVL)(at 36 weeks' gestational age or before discharge from hospital)
- patent ductus arteriosis(PDA)(at 36 weeks' gestational age or before discharge from hospital)
- air leak(at 36 weeks' gestational age or before discharge from hospital)
- intraventricular hemorrhage(IVH)(before discharge or 36 weeks' gestational age)
- necrotizing enterocolitis(NEC)(at 36 weeks' gestational age or before discharge from hospital)
研究者
Chen Long,MD
director
Children's Hospital of Chongqing Medical University