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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04606589
Other study ID # MSU/DRPI/MUERC/00864/20
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 1, 2021
Est. completion date May 30, 2021

Study information

Verified date October 2020
Source Neopenda, PBC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Day to 28 Days
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Kenya Kakamega County Referral Hospital Kakamega

Sponsors (2)

Lead Sponsor Collaborator
Neopenda, PBC Center for Public Health and Development

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary 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
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