Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
研究概览
简要总结
To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.
详细描述
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:
i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Days 至 70 Days（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
- •Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
- •Postnatal age between 21 days and 70 days
- •Informed written consent obtained from at least one of the parents.
排除标准
- •Need for mechanical ventilation, NCPAP or O2
- •Sepsis or other known causes of apnea.
结局指标
主要结局
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
时间窗: 3 months
次要结局
- To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern(3 months)