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NCT Number: NCT04606589

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

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.

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Key information

Conditions

Newborn Morbidity Newborn Complication

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Kakamega County Referral Hospital

Kakamega, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. In-hospital newborn mortality

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

    Proportion of deaths that occur during hospital stay.

Secondary outcomes

  1. Complication rate

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

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

  2. Length of stay in hospital

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

    Time elapsed between admission and discharge of a patient (measured in days).

Other outcomes

  1. Mean alarm-response time

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

    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).

Sponsors and collaborators

Lead sponsor

Neopenda, PBC

Industry

Collaborators

  • Center for Public Health and Development

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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