Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants: The Canadian Oxygen Trial (COT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,201
- 试验地点
- 43
- 主要终点
- Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
研究概览
简要总结
Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?
详细描述
Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 23 0/7 - 27 6/7 weeks
- •Postnatal age < 24 hours
排除标准
- •Infant not considered viable (decision made not to administer effective therapies)
- •Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
- •Known or strongly suspected cyanotic heart disease
- •Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
- •Unlikely to be available for long-term follow-up
研究组 & 干预措施
1
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
干预措施: Titration of oxygen therapy (Other)
2
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 91-95%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
干预措施: Titration of oxygen therapy (Other)
结局指标
主要结局
Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
时间窗: 18-21 months corrected for prematurity
次要结局
- Growth(until 18-21 months corrected for prematurity)
- respiratory morbidity(until 18-21 months corrected for prematurity)
- Retinopathy of prematurity(32 to 44 weeks postmenstrual age)
- Bronchopulmonary dysplasia(36 weeks postmenstrual age)
- Brain injury(from week one of life up to 36 weeks postmenstrual age)
- Patent ductus arteriosus(until first discharge home)
- Necrotizing enterocolitis(until first discharge home)
- Mean developmental index scores on the Bayley Scales(18-21 months corrected for prematurity)