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

Neopenda

Status and phase: Completed; Early Phase 1

Conditions: Newborn Complication; Newborn Morbidity

Treatments: Device: neoGuard vital signs monitor

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04606589

MSU/DRPI/MUERC/00864/20

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Standard-of-care

No Intervention group

Description:

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.

neoGuard vital signs monitor

Experimental group

Description:

The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device.

Treatment:

Device: neoGuard vital signs monitor