Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
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
- Hypoxemic episode
研究概览
简要总结
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
详细描述
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist.
For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study.
The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
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 Day 至 98 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (<29 weeks) inclusive completed weeks of gestation
- •Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
- •Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age
- •This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist
- •Informed consent from parent/guardian
排除标准
- •Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
结局指标
主要结局
Hypoxemic episode
时间窗: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) \<85% for \>10 seconds
次要结局
- Apnea episodes(During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment))
- Bradycardic episode(During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment))
- Hypoxemic time defined as duration of time with SpO2 <85%(During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment))
研究者
Namasivayam Ambalavanan
Principal Investigator
University of Alabama at Birmingham