Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- ventilatory stability by density of periodic breathing
研究概览
简要总结
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 0/7- 29 6/7 weeks gestational age
- •Postnatal age ≥ 14 days
- •Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
- •Parental informed consent
排除标准
- •Severe congenital anomalies that may affect pulmonary or neurosensory development
- •Severe CNS pathology that may alter respiratory control function
研究组 & 干预措施
Targeting SpO2 at 93-95% followed by targeting at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
干预措施: Targeting SpO2 at 93-95% (Other)
Targeting SpO2 at 93-95% followed by targeting at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
干预措施: Targeting SpO2 at 90-92% (Other)
Targeting SpO2 at 90-92% followed by targeting at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.
干预措施: Targeting SpO2 at 93-95% (Other)
Targeting SpO2 at 90-92% followed by targeting at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.
干预措施: Targeting SpO2 at 90-92% (Other)
结局指标
主要结局
ventilatory stability by density of periodic breathing
时间窗: 2 hours
by density of periodic breathing
ventilatory stability by frequency of central apnea
时间窗: 2 hours
by frequency of central apnea
ventilatory stability by frequency of obstructive apnea
时间窗: 2 hours
by frequency of obstructive apnea
ventilatory stability by time series of inter-breath intervals
时间窗: 2 hours
by time series of inter-breath intervals
次要结局
- frequency of bradycardia episodes(2 hours)
- oxygenation stability by frequency of intermittent hypoxemia episodes(2 hours)
研究者
Nelson Claure
Associate Professor of Pediatrics
University of Miami