Evaluation of Technologies for Neonates in Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 575
- 试验地点
- 2
- 主要终点
- Determine the accuracy the investigational devices: Agreement of the relevant measurement
研究概览
简要总结
This is a diagnostic accuracy evaluation and clinical feasibility study of investigational devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are admitted for routine observation and care will be enrolled.
详细描述
To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research is needed to develop and optimize innovations in neonatal care, specifically technologies that are low cost, operator-independent, and highly efficient. The purpose of this study is to produce information and data regarding the performance of two existing multiparameter continuous physiological monitoring devices developed by device developers, EarlySense and Sonica. The clinical trial is intended to provide evidence to establish whether these investigational devices can reliably and accurately measure vital signs in neonates (when compared to verified reference devices) and to assess the feasibility, usability and acceptability of these devices for use in neonates in a LRS in Africa.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female neonate, corrected age of ≤ 28 days.
- •Willingness and ability of neonate's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study.
排除标准
- •Receiving mechanical ventilation or continuous positive airway pressure (CPAP).
- •Skin abnormalities in the nasopharynx and/or oropharynx.
- •Contraindication to application of skin sensors.
- •Known arrhythmia.
- •Presence of a congenital abnormality requiring major surgical intervention.
- •Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the neonate's health.
结局指标
主要结局
Determine the accuracy the investigational devices: Agreement of the relevant measurement
时间窗: Measurements will be collected at one minute intervals for a minimum of 1 hour
Agreement of the relevant measurement parameters of interest between the investigational device and the reference device(s) at each observation
Assess the feasibility, usability and acceptability of the investigational device: questionnaire
时间窗: One 30 minute in-depth interview
Qualitative questionnaire
Determine the clinical feasibility of the investigational devices: Agreement of clinical event detection
时间窗: Measurements collected at one minute intervals for a minimum of 1 hour
Agreement of clinical event detection between the investigational device and the reference device(s) at each observation.
次要结局
未报告次要终点