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

Newborn Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606589
• Other study ID #: MSU/DRPI/MUERC/00864/20
• Status: Completed
• Phase: Early Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Critical Illness
• Newborn Complication
• Newborn Morbidity

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