Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC)
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 late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.
详细描述
Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by Attending neonatologist will qualify.
The investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age.
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 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 15 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
- •Informed consent from parent/guardian
- •This study will enroll the subset of infants from Aim 1 who are still intubated or on nasal IMV at 2 weeks postnatal age, meet blood gas criteria (arterial or capillary arterialized blood gas values done q12-24h, as most infants do not have an arterial line at 2 weeks: pH >7.25, PaCO2 >40 mm Hg), have TcCO2 monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by the Attending neonatologist.
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 targeted transcutaneous carbondioxide (TcCO2)
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2 )\<85% for \>10 seconds
次要结局
- Bronchopulmonary dysplasia (BPD)(36 weeks PMA)
- Hypoxemic time(During 24 hour time periods with targeted TcCO2)
- Bradycardic episode(During 24 hour time periods with targeted TcCO2)
- Apnea episodes(During 24 hour time periods with targeted TcCO2)
研究者
Namasivayam Ambalavanan
Principal Investigator
University of Alabama at Birmingham