Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The number of episodes with oxygen saturations less than 85% for ≥10 seconds
研究概览
简要总结
The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention.
This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.
详细描述
In preterm infants < 37 weeks' gestation at birth requiring oxygen without ventilatory/CPAP support, will oxygen environment decrease the number of episodes with oxygen saturations less than 85% for ≥ 10 seconds in a 48 hour cross-over period on either intervention compared with nasal cannula oxygen?
The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of randomized controlled trials of oxygen saturation targets which included data on 4911 infants from the SUPPORT, COT, and BOOST II trials.
This study will include preterm infants < 37 weeks' gestation on oxygen therapy via OE or NC with flow rates ≤ 1.0 l/kg/min. There will be three randomization strata [≥ 22+0/7 to ≤ 25+6/7 weeks, ≥ 26+0/7 to ≤ 28+6/7 weeks, ≥ 29+0/7 to ≤ 36+6/7 weeks' gestation]. The purpose of stratification is to ensure an appropriate distribution of risk between study arms. This study will not be powered to detect outcome differences within or between strata.
Following informed consent, randomization, stratified by gestational age at delivery, will be performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate either Treatment group (OE group) or Control group (NC group). The envelope will only be opened after informed consent has been obtained and just before starting the study on each infant.
This will be a single center randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention and a 15-30 minute washout period, infants will cross-over to a 24 hour period of the second/alternate intervention. Following a further 15-30 minute washout period, infants will cross-over to a 24 hour period on the first intervention. Following another 15-30 minute washout period, infants will cross-over to a 24 hour period on the second/alternate intervention. The effective FiO2 will be calculated for all infants based on their oxygen therapy modality prior to the monitoring period and used to swap between modes.
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
- 1 Hour 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant requiring supplemental oxygen therapy via oxygen environment (OE) or nasal cannula (NC) with flow rates ≤ 1.0 liter per kilogram per minute
- •Off ventilatory support and/or NCPAP for > 48 hours prior to study entry
- •Gestational age < 37 weeks' gestation at birth
- •Nursed in incubator for thermoregulation
- •Parents/legal guardians have provided consent for enrollment
排除标准
- •A major malformation
- •A neuromuscular condition that affects respiration
- •Terminal illness or decision to withhold or limit support
结局指标
主要结局
The number of episodes with oxygen saturations less than 85% for ≥10 seconds
时间窗: During a 48 hour cross-over period on either intervention
次要结局
- The proportion of time with oxygen saturations > 95%(During a 48 hour cross-over period on either intervention)
- The coefficient of variation (relative standard deviation) of oxygen saturations(During a 48 hour cross-over period on either intervention)
- The proportion of time spent outside oxygen saturation target ranges (91-95 %)(During a 48 hour cross-over period on either intervention)
- The proportion of time with oxygen saturations less than 85 %(During a 48 hour cross-over period on either intervention)
- The effective fraction of inspired oxygen (FiO2) requirement(During a 48 hour cross-over period on either intervention)
- The number of recorded interventions with tactile stimulation/blow by oxygen/CPAP/IPPV(During a 48 hour cross-over period on either intervention)
- The number of adjustments in FiO2 recorded in the electronic medical record(During a 48 hour cross-over period on either intervention)
- The number of episodes (≥ 10 seconds) with oxygen saturations less than 80%(During a 48 hour cross-over period on either intervention)
- The number of recorded episodes of bradycardia <80/min(During a 48 hour cross-over period on either intervention)
研究者
Colm Travers
Principal Investigator
University of Alabama at Birmingham