Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
NCT ID: NCT05728307
Last Updated: 2023-11-15
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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RECRUITING
3000 participants
OBSERVATIONAL
2022-11-28
2023-11-30
Brief Summary
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1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner).
The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.
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Detailed Description
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In December 2022, neoGuard was installed in 4 sub-units (intervention group), while the remaining 4 sub-units (comparison group) continued to use standard-of-care monitoring.
The measurement of effectiveness will be performed at three levels: (1) device's ability to detect abnormal physiological signals and provide alerts/alarms that notify the nurses to check on a patient's status and; (2) alarms/alerts from level one that resulted in a necessary intervention being administered to the patient (valid alarms), versus all the alarms/alerts that did not necessitate an intervention (invalid alarms); (3) the month-to-month difference in newborn complication rates and treatment outcomes between the intervention group and comparison group.
Medical staff who interact with neoGuard will participate in user surveys at the end of the intervention period to capture user experience and perceptions on feasibility and sustainability.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention Group
The intervention group consists of patients admitted to the 4 neonatal subunits where neoGuard was installed: the preterm units (category A and category B), and the high dependence units (HDU-1 and HDU-2).
neoGuard vital signs monitor
The neoGuard device is a 4-in-1 wearable vital signs monitor developed by Neopenda, PBC (Chicago, Illinois). The system is designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2). It contains two non-invasive sensors: an optical reflectance pulse oximeter and a digital temperature sensor. These sensors measure signals from the surface of the patient's skin, and algorithms within the device calculate the pulse rate, respiratory rate, SpO2 and temperature.
The device is made of medical grade polyetherimide plastic and can be worn on the forehead through an adjustable band. The PR, RR, temperature and SpO2 data are collected, recorded and transmitted via Bluetooth Low Energy (BLE) to a tablet which can be placed within a range of 20-30 meter distance. The neoGuard technology has received CE mark certification and is also registered with the Kenya Pharmacy and Poisons Board (KPPB).
Comparison Group
The comparison group consists patients admitted 4 subunits where neoGuard was not installed: the neonatal intensive care unit (NICU), the KMC/category C room, the isolation room and the stable full-term room. These subunits will receive the standard-of-care/current practice, which consists of either a bedside cardiac monitor or intermittent monitoring every 3 hours using manual equipment such as hand-held pulse oximeters for pulse rate and oxygen saturation, digital axillary thermometers for temperature, and manual counting of breaths for respiratory rate.
No interventions assigned to this group
Interventions
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neoGuard vital signs monitor
The neoGuard device is a 4-in-1 wearable vital signs monitor developed by Neopenda, PBC (Chicago, Illinois). The system is designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2). It contains two non-invasive sensors: an optical reflectance pulse oximeter and a digital temperature sensor. These sensors measure signals from the surface of the patient's skin, and algorithms within the device calculate the pulse rate, respiratory rate, SpO2 and temperature.
The device is made of medical grade polyetherimide plastic and can be worn on the forehead through an adjustable band. The PR, RR, temperature and SpO2 data are collected, recorded and transmitted via Bluetooth Low Energy (BLE) to a tablet which can be placed within a range of 20-30 meter distance. The neoGuard technology has received CE mark certification and is also registered with the Kenya Pharmacy and Poisons Board (KPPB).
Eligibility Criteria
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Inclusion Criteria
* The newborn's parent/guardian must provide informed consent to use the neoGuard system on their newborn.
Exclusion Criteria
* Receiving palliative care
* Patients undergoing phototherapy
* Those with open head injuries/lacerations
* Those receiving treatment that might interfere with application of the neoGuard device
0 Days
28 Days
ALL
No
Sponsors
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Academic Model Providing Access to Healthcare (AMPATH)
OTHER
DLR German Aerospace Center
OTHER
Assumpta Solome Nantume
INDUSTRY
Responsible Party
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Assumpta Solome Nantume
Research & Evaluation Lead
Principal Investigators
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Festus Njuguna, MMed
Role: PRINCIPAL_INVESTIGATOR
Moi Teaching and Referral Hospital/Moi University
Locations
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Moi Teaching and Referral Hospital
Eldoret, , Kenya
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FAN:0003994
Identifier Type: -
Identifier Source: org_study_id
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