Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
NCT ID: NCT04606589
Last Updated: 2023-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
167 participants
INTERVENTIONAL
2021-02-01
2021-05-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Standard-of-care
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.
No interventions assigned to this group
neoGuard vital signs monitor
The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
1 Day
28 Days
ALL
No
Sponsors
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Center for Public Health and Development
UNKNOWN
Neopenda, PBC
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard Olayo, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Public Health and Development
Locations
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Kakamega County Referral Hospital
Kakamega, , Kenya
Countries
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Other Identifiers
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MSU/DRPI/MUERC/00864/20
Identifier Type: -
Identifier Source: org_study_id
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