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

Early Phase 1CompletedNCT04606589

Neopenda, PBC167 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

167

Conditions

Newborn Morbidity Newborn Complication

Interventions

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

In-hospital newborn mortality

Proportion of deaths that occur during hospital stay.

Time frame: From date of admission to date of discharge or referral or death, up to 28 days

Secondary Outcomes

Complication rate

Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care.

Time frame: 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).

Time frame: From date of admission to date of discharge or referral or death, up to 28 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes