Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- In-hospital newborn mortality
研究概览
简要总结
The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.
This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <28 days
- •Admitted to the neonatal intensive care unit
- •Weight at birth/admission ≥2000 g
- •Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
- •Parent/guardian willing to provide informed consent for their newborn to participate in study
排除标准
- •Age >28 days
- •Has a condition that impairs them from wearing the device, such as hydrocephaly.
- •Weight at birth <2000 g
- •Very severe disease status (SICK score >2.4 at admission)
结局指标
主要结局
In-hospital newborn mortality
时间窗: From date of admission to date of discharge or referral or death, up to 28 days
Proportion of deaths that occur during hospital stay.
次要结局
- Complication rate(From date of admission to date of discharge or referral or death, up to 28 days)
- Length of stay in hospital(From date of admission to date of discharge or referral or death, up to 28 days)