Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

RecruitingOBSERVATIONAL
Enrollment

3,000

Participants

Timeline

Start Date

November 28, 2022

Primary Completion Date

June 30, 2023

Study Completion Date

November 30, 2023

Conditions
Newborn ComplicationNewborn Morbidity
Interventions
DEVICE

neoGuard vital signs monitor

"The neoGuard device is a 4-in-1 wearable vital signs monitor developed by Neopenda, PBC (Chicago, Illinois). The system is designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2). It contains two non-invasive sensors: an optical reflectance pulse oximeter and a digital temperature sensor. These sensors measure signals from the surface of the patient's skin, and algorithms within the device calculate the pulse rate, respiratory rate, SpO2 and temperature.~The device is made of medical grade polyetherimide plastic and can be worn on the forehead through an adjustable band. The PR, RR, temperature and SpO2 data are collected, recorded and transmitted via Bluetooth Low Energy (BLE) to a tablet which can be placed within a range of 20-30 meter distance. The neoGuard technology has received CE mark certification and is also registered with the Kenya Pharmacy and Poisons Board (KPPB)."

Trial Locations (1)

Unknown

RECRUITING

Moi Teaching and Referral Hospital, Eldoret

All Listed Sponsors
collaborator

Academic Model Providing Access to Healthcare (AMPATH)

OTHER

collaborator

DLR German Aerospace Center

OTHER

lead

Assumpta Solome Nantume

INDUSTRY