Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Average duration of controlled oxygen therapy in a premature infant
研究概览
简要总结
The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.
详细描述
The project is a national, prospective, multicenter, interventional pilot project focused on remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.
The main goal of the project is validation of the possibility and organization of remotely managed home oxygen therapy and its optimization, aiming for its earlier termination.
The project will be running in 4 perinatology centers in the Czech Republic. It is expected that 70 premature infants diagnosed with bronchopulmonary dysplasia will participate. The infant must transition to low-flow nasal cannulas to be discharged to home care. Oxygen therapy will be adjusted based on pre-established protocols aiming for earlier and safer termination of oxygen therapy through precise remote continual monitoring.
The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants born before 31+6 weeks gestation
- •signed consent for participation in the project and consent for the processing of personal data
- •diagnosed with bronchopulmonary dysplasia
- •type of pulmonary ventilation - low-flow nasal cannulas
排除标准
- •unsigned consent for participation in the project and/or consent for the processing of personal data
- •child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea
- •other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration
- •insufficient therapy through long-term home oxygen therapy
- •tracheostomy
结局指标
主要结局
Average duration of controlled oxygen therapy in a premature infant
时间窗: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
Number of days a premature infant stays on oxygen therapy
次要结局
- Average number of failures in premature infants before the termination of controlled oxygen therapy(From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply))