Non-invasive Monitoring of Newborns in the First Hours of Life for the Prevention of SUPC (Sudden Unexpected Postnatal Collapse): Interventional Study With Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- prodromal events of SUPC
研究概览
简要总结
The application of non-invasive monitoring via a wearable device in newborns during the first 48-72 hours of life could enable early recognition and timely management of episodes that may result in SUPC, thereby improving clinical practice.
详细描述
SUPC is a rare event, with maximum incidence in the first 2 hours of life of the newborn. Despite the rarity of events, the consequences can be dramatic, with a high risk of death and severe neurological disabilities. To date, prevention of events is based on serial clinical monitoring of newborns during skin-to-skin contact.
Some non-invasive monitoring systems integrated into wearable textiles have proven to be reliable and are well tolerated by newborns, families, and healthcare personnel.
The application of non-invasive monitoring via a wearable device in newborns during the first 48-72 hours of life could enable early recognition and timely management of episodes that may result in SUPC, thereby improving clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ³ 35 weeks
- •Apgar score at 5 minutes ³ 8
- •Acquisition of written informed consent from the parent/guardian
排除标准
- •Major congenital malformations
- •Family history of silver allergy
结局指标
主要结局
prodromal events of SUPC
时间窗: 72 hours
Measure how many prodromal events of SUPC (bradycardia, bradypnea, apnea) are detected with the ComfTech HOWDY BABY device (ComfTech S.r.l.), outside the times scheduled for clinical monitoring in the first 72 hours of life of newborns.
次要结局
未报告次要终点
研究者
Luigi Corvaglia
PI
IRCCS Azienda Ospedaliero-Universitaria di Bologna