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

NCT05728307 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2023-11-15

No results posted yet for this study

Summary

The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are:

1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner).

The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.

Conditions

  • Newborn Complication
  • Newborn 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).

Sponsors & Collaborators

  • Academic Model Providing Access to Healthcare (AMPATH)

    collaborator OTHER

  • DLR German Aerospace Center

    collaborator OTHER

  • Assumpta Solome Nantume

    lead INDUSTRY

Principal Investigators

  • Festus Njuguna, MMed · Moi Teaching and Referral Hospital/Moi University

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-06-30
Completion
2023-11-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728307 on ClinicalTrials.gov