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

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.

Study Overview

• Status: Completed
• Conditions: Newborn Morbidity; Newborn Complication
• Intervention / Treatment: Device: neoGuard vital signs monitor

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Kenya
  • Kakamega, Kenya
    • Kakamega County Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age <28 days
• Admitted to the neonatal intensive care unit
• Weight at birth/admission ≥2000 g
• Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
• Parent/guardian willing to provide informed consent for their newborn to participate in study

Exclusion Criteria:

• Age >28 days
• Has a condition that impairs them from wearing the device, such as hydrocephaly.
• Weight at birth <2000 g
• Very severe disease status (SICK score >2.4 at admission)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard-of-care; The standard-of-care arm will receive intermittent monitoring of pulse rate and blood oxygen saturation with a conventional pulse oximeter. Temperature and respiratory rate will also be monitored intermittently with a digital thermometer and manual counting of breaths respectively.
Experimental: neoGuard vital signs monitor; The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital newborn mortality	Proportion of deaths that occur during hospital stay.	From date of admission to date of discharge or referral or death, up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care.	From date of admission to date of discharge or referral or death, up to 28 days
Length of stay in hospital	Time elapsed between admission and discharge of a patient (measured in days).	From date of admission to date of discharge or referral or death, up to 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean alarm-response time	Average time elapsed between when each neoGuard alarm goes off and when a nurse attends to the patient (measured in seconds by the Neopenda app).	From date of admission to date of discharge or referral or death, up to 28 days

Collaborators and Investigators

• Sponsor: Neopenda, PBC
• Collaborators: Center for Public Health and Development
• Investigators: Principal Investigator: Bernard Olayo, MD, Center for Public Health and Development

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Newborn health; Newborn morbidity; Newborn critical care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: MSU/DRPI/MUERC/00864/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No