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

Early Phase 1

Completed

• Conditions: Newborn Morbidity; Newborn Complication
• Interventions: Device: neoGuard vital signs monitor

• Registration Number: NCT04606589
• Lead Sponsor: Neopenda, PBC

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Study Start: 2021-02-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoGuard vital signs monitor	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kakamega County Referral Hospital; 🇰🇪 Kakamega, Kenya