NCT04606589

Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Neopenda, PBC · Industry
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Newborn Morbidity
• Newborn Complication

Interventions

Type	Name	Description
DEVICE	neoGuard vital signs monitor	The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2020-10-28
• Last updated: 2023-03-23

Locations

1 site across 1 country: Kenya