NCT03920761

Evaluation of Technologies for Neonates in Africa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 575 (actual)
• Sponsor: Save the Children · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neonatal Physiology

Interventions

Type	Name	Description
DEVICE	EarlySense Insight system	a small piezoelectric sensor pad that can be placed under the mattress and provide contact-free monitoring by measuring and recording a patient's vital signs and motion parameters
DEVICE	Advanced Neonatal Epidermal System	a system of neonatal non-invasive adhesive sensors. Sensors are attached directly on the patient's body and are capable of continuously measuring and recording heart rate, respiratory rate, oxygen saturation, and skin temperature.

Timeline

• Start date: 2019-06-27
• Primary completion: 2020-12-15
• Completion: 2020-12-30
• First posted: 2019-04-19
• Last updated: 2021-02-17

Locations

2 sites across 1 country: Kenya

Regulatory

• FDA-regulated device study