Feasibility of Respiratory Management of Infants Needing Positive Pressure Ventilation or CPAP, Using a Single System to Deliver Uninterrupted Support Directly at Birth and the First Hours of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cause of each interruption in CPAP treatment
研究概览
简要总结
Feasibility study of a simplified respiratory support system for newborn infants
详细描述
The study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. The study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system.
The system is a modified version of the commercially available rPAP system. The revised design has a simplified gas supply and allows elimination of a complicated driver. The new system has low resistance to breathing equal to the rPAP system. The study will recruit 40-60 infants in a single centre without a comparison arm.
The trial is conducted as a first step towards a large randomised trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaginal delivery at gestational age between 28+0 and 34+6
- •Caesarean section at gestational age between 28+0 and 37+6
- •Infants in need of respiratory support in delivery-room
排除标准
- •Carciac malformations
- •Airway malformations
- •Known syndromes or neuromuscular disorders
- •Transfer to other hospital within 4 hours likely
结局指标
主要结局
Cause of each interruption in CPAP treatment
时间窗: 0-240 minutes
Reported reason for interruptions in CPAP treatment (free text as reported by staff)
Number of interruptions in CPAP treatment
时间窗: 0-240 minutes
Number of CPAP-support interruptions (n)
Duration of interruptions in CPAP treatment
时间窗: 0-240 minutes
Duration CPAP support interruptions (min)
次要结局
- Respiratory support at 48 hours(0-240 minutes)
- Ease of use: Fixation and transport(0-60 minutes)
- Level of respiratory support(0-240 minutes)
- Ease of use: Respiratory support system set up(0-10 minutes)
- Ease of use: Airway and respiratory supportmanagement(0-60 minutes)
- Rare events in clinical management(0-240 minutes)
- Adverse events and safety(0-240 minutes)
- Response to respiratory support(0-240 minutes)
研究者
Thomas Drevhammar
Senior Consultant, PhD
Karolinska Institutet