Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
详细描述
To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth.
According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS.
Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.
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
- 30 Minutes 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infant less than 28 days
- •diagnosis of ARDS or RDS or both
- •informed parental consent has been obtained
排除标准
- •major congenital malformations or complex congenital heart disease or chromosomal abnormalities
- •transferred out of the neonatal intensive care unit without treatment
- •upper respiratory tract abnormalities
研究组 & 干预措施
surfactant combined with mechanical ventilation
surfactant is given to the infant with ARDS.
干预措施: surfactant combined with mechanical ventilation (MV) (Drug)
mechanical ventilation
mechanical ventilation is given to the infant with ARDS.
干预措施: mechanical ventilation (MV) (Drug)
结局指标
主要结局
death
时间窗: at 36 weeks' gestational age or before discharge from hospital
neonates died
bronchopulmonary dysplasia(BPD)
时间窗: at 36 weeks' gestational age or before discharge from hospital
neonates were diagnosed with BPD
BPD and/or death
时间窗: at 36 weeks' gestational age or before discharge from hospital
neonates were diagnosed with BPD and/or death
次要结局
- Bayley Scales of Infant Development(at 2 months old and 2 years old)
- haemodynamically significant patent ductusarteriosus (hsPDA)(at 36 weeks' gestational age or before discharge from hospital)
- retinopathy of prematurity (ROP)> 2nd stages(at 36 weeks' gestational age or before discharge from hospital)
- necrotizing enterocolitis (NEC) ≥ 2nd stages(at 36 weeks' gestational age or before discharge from hospital)
- intraventricular hemorrhage(IVH)>2nd grades(at 36 weeks' gestational age or before discharge from hospital)
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University