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

Study Overview
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Brief Summary
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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.

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

Conditions
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Newborn Morbidity, Newborn Complication

Intervention / Treatment
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* Device: neoGuard vital signs monitor


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a simple pre/post interventional study model.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard-of-care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn health, Newborn morbidity, Newborn critical care