Automated Oxygen Control for Preterm Infants On Continuous Positive Airway Pressure (CPAP): Phase 1/2 Trial In Southwest Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Proportion of time in target SpO2 range
研究概览
简要总结
One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA). Low flow oxygen, and respiratory support - where an oxygen/air mixture is delivered under pressure - are life saving therapies for these babies. Bubble Continuous Positive Airway Pressure (bCPAP) is the mainstay of neonatal respiratory support in SSA.
Oxygen in excess can damage the immature eyes (Retinopathy of Prematurity [ROP]) and lungs (Chronic Lung Disease) of preterm babies. Historically, in well-resourced settings, excessive oxygen administration to newborns has been associated with 'epidemics' of ROP associated blindness. Today, with increasing survival of preterm babies in SSA, and increasing access to oxygen and bCPAP, there are concerns about an emerging epidemic of ROP. Manually adjusting the amount of oxygen provided to an infant on bCPAP is difficult, and fearing the risks of hypoxaemia (low oxygen levels) busy health workers often accept hyperoxaemia (excessive oxygen levels). Some well resourced neonatal intensive care units globally have adopted Automated Oxygen Control (AOC), where a computer uses a baby's oxygen saturation by pulse oximetry (SpO2) to frequently adjust how much oxygen is provided, targetting a safe SpO2 range. This technology has never been tested in SSA, or partnered with bCPAP devices that would be more appropriate for SSA.
This study aims to compare AOC coupled with a low cost and robust bCPAP device (Diamedica Baby CPAP) - OxyMate - with manual control of oxygen for preterm babies on bCPAP in two hospitals in south west Nigeria. The hypothesis is that OxyMate can significantly and safely increase the proportion of time preterm infants on bCPAP spend in safe oxygen saturation levels.
详细描述
Trial description: A randomised cross-over trial of manual versus automated control of oxygen (OxyMate) for preterm infants on bCPAP. This trial will use an established technology (automated oxygen titration algorithm, VDL1.1) partnered with a low-cost bCPAP device in a low-resource setting. It will involve preterm infants requiring bCPAP respiratory support with allocation to OxyMate or manual oxygen control for consecutive 24 h periods in random sequence.
Objectives: This trial seeks to examine safety and potential efficacy of our automated oxygen configuration (OxyMate) in preterm infants in a setting characterised by financial constraints, workforce limitations, and underdeveloped infrastructure, and assess contextual feasibility and appropriateness to inform future definitive clinical trials and product development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Hours 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<34 weeks gestation (or birth weight < 2kg if gestation not known)
- •≥12 hours old
- •Receiving CPAP support and supplemental oxygen (FiO2 >0.21) for respiratory insufficiency
- •Projected requirement for CPAP and oxygen therapy for > 48 hours
排除标准
- •Deemed likely to fail CPAP in the next 48 hours
- •Deemed clinically unstable or recommended for palliation by treating team
- •Cause of hypoxaemia likely to be non-respiratory - e.g. cyanotic heart disease
- •Informed consent from parent/guardians not obtained
结局指标
主要结局
Proportion of time in target SpO2 range
时间窗: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) in the target SpO2 range (91-95%, or 91-100% when in room air). Measured as %time
次要结局
- Proportion of time in severe hypoxaemia(Measured for each 24 hour study epoch)
- Costs(Measured at completion of OxyMate study: an estimated 20 weeks)
- Proportion of time in target SpO2 range when receiving supplemental oxygen(Measured for each 24 hour study epoch)
- Proportion of time in hypoxaemia(Measured for each 24 hour study epoch)
- No response to prolonged severe hypoxaemia (frequency)(Measured for each 24 hour study epoch)
- Time on low flow oxygen(Completed for each participant at end of their study period: 49 hours from study commencement)
- Frequency of prolonged hypoxaemia episodes(Measured for each 24 hour study epoch)
- Proportion of time in hyperoxaemia(Measured for each 24 hour study epoch)
- Severe hypoxaemia with bradycardia (frequency)(Measured for each 24 hour study epoch)
- Acceptability and usability(Completed for each participant (health workers) at end of an infant's study period (49 hours). Results recorded for unique health workers through to OxyMate study completion: estimated 20 weeks)
- Duration of CPAP and oxygen therapy(Completed for each participant at end of their study period: 49 hours from study commencement)
- Final discharge outcome(Up to 4 weeks post enrollment)
- Length of stay(Up to 4 weeks post enrollment)
- Device malfunction(Measured through to OxyMate study completion: estimated 20 weeks)
- CPAP in room air(Completed for each participant at end of their study period: 49 hours from study commencement)
- Proportion of time in severe hyperoxaemia(Measured for each 24 hour study epoch)
- Frequency of prolonged hyperoxaemia episodes(Measured for each 24 hour study epoch)
- Manual FiO2 adjustments(Measured for each 24 hour study epoch)
- No response to prolonged severe hypoxaemia (duration)(Measured for each 24 hour study epoch)
- Severe hypoxaemia with bradycardia (duration)(Measured for each 24 hour study epoch)