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

NCT04606589 | Completed Early Phase 1

• 1 other identifier: MSU/DRPI/MUERC/00864/20
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newborn Morbidity; Newborn Complication

Keywords

Newborn health; Newborn morbidity; Newborn critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complication rate

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

• Length of stay in hospital

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

Other Outcomes (1)

• Mean alarm-response time

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

Study Arms (2)

Standard-of-care

NO INTERVENTION

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

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

Interventions

neoGuard vital signs monitor DEVICE

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.

neoGuard vital signs monitor

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Neopenda, PBC: lead
• Center for Public Health and Development: collaborator

Study Sites (1)

Kakamega County Referral Hospital

Kakamega, Kenya

Location

Study Officials

• Bernard Olayo, MD

  Center for Public Health and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a simple pre/post interventional study model.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 28, 2020
• Study Start: February 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: March 23, 2023

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)