A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Failure of Support
概览
简要总结
The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is:
Does Pressure Targeted High Flow provide enough support in premature infants?
Participants will:
Take spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.
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
- 7 Days 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delivery at \>24+0 weeks and ≤32+6 weeks of gestation
- •Postnatal age \>7 days but \< 6 weeks old
- •Weight ≥1,000grams at the time of study
- •Receiving clinically prescribed CPAP at pressures of 5-8cm H2O
- •Requiring an FiO2 of ≤0.60
排除标准
- •Chromosomal disorder (aneuploidy)
- •Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)
- •Prior pneumothorax
- •Infants in whom chance of survival is uncertain
研究组 & 干预措施
PTHF First
PTHF prior to CPAP
干预措施: Pressure Targeted High Flow (Procedure)
CPAP First
CPAP prior to PTHF
干预措施: CPAP (Procedure)
结局指标
主要结局
Failure of Support
时间窗: 24 hours
Failure of respiratory support as defined by increase in fraction of inspired oxygen (FiO2) of ≥0.10, a pH of ≤7.2 with a CO2 ≥60 mm Hg, an increase in transcutaneous CO2 of ≥15mmHg above baseline or ≥2 episodes of apnea requiring positive-pressure ventilation
次要结局
- Oxygenation(24 hours)
- Respiratory Rate(24 hours)
- Infant comfort - NIPE(24 hours)
- Infant Comfort - Parent(24 hours)
- Resource Use(24 hours)
研究者
Alan Groves
Professor of Pediatrics
University of Texas at Austin