The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,973
- 试验地点
- 29
- 主要终点
- Need for mechanical ventilation
研究概览
简要总结
A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.
详细描述
The rationale for this study is the clinical relevance of understanding whether surfactant dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal period.
In a research environment, the dose of surfactant is rigorously controlled, usually administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get as close as possible to the desired dose. Reasons for whole vial use include reduction of waste and administration of surfactant shortly after birth where an infant's weight is unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and whether either situation affects outcomes.
Information regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the UK.
The primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200 mg/kg) in terms of the proportions of infants who require mechanical ventilation within four days of birth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation
排除标准
- •37 weeks gestation age or above Parental opt-out
结局指标
主要结局
Need for mechanical ventilation
时间窗: Day 3 to 4 of life
Survival without mechanical ventilation (excluding days 1 and 2 of life)
次要结局
- Total cumulative dose of surfactant (excluding the first dose)(To study completion, an average of 2 years)
- Survival with no oxygen requirement(To study completion, an average of 2 years)
- Duration of mechanical ventilation (days)(To study completion, an average of 2 years)
- Duration of respiratory support (days)(To study completion, an average of 2 years)
- Survival(To study completion, an average of 2 years)
- Number of doses of surfactant(To study completion, an average of 2 years)
- Survival with no respiratory support(36 weeks gestation)
- Two-year developmental outcomes(Two years)