Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

Newborn Morbidity Clinical Trial

Official title:

Evaluating the Clinical Impact and Cost-effectiveness of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728307
• Other study ID #: FAN:0003994
• Status: Recruiting
• Start date: November 28, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: Neopenda, PBC
• Contact: Assumpta S Nantume, MSc
• Phone: 2037472391
• Email: assumpta[@]neopenda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are:

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.

Description:

This is an interrupted time series study conducted at the Moi Teaching and Referral Hospital (MTRH) neonatal ward between April 2022 and June 2023. Our study participants comprise of newborn patients admitted at MTRH during that period. The MTRH neonatal ward is arranged in 8 sub-units which comprise our comparison sub-groups. Newborns admitted from April-November 2022 comprise the pre-intervention arm and are not exposed to neoGuard, but receive existing standard-of-care vital sign monitoring.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

Inclusion Criteria:

• Must be admitted to one of the subunits assigned to receive the intervention (i.e., APU category A or B, the HDU-1 or HDU-2)

• The newborn's parent/guardian must provide informed consent to use the neoGuard system on their newborn.

Exclusion Criteria:

• Assessed to have congenital anomalies that are incompatible with life

• Receiving palliative care

• Patients undergoing phototherapy

• Those with open head injuries/lacerations

• Those receiving treatment that might interfere with application of the neoGuard device

Related Conditions & MeSH terms

• Newborn Complication
• Newborn Morbidity

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Kenya	Moi Teaching and Referral Hospital	Eldoret

Sponsors (3)

Lead Sponsor	Collaborator
Assumpta Solome Nantume	Academic Model Providing Access to Healthcare (AMPATH), DLR German Aerospace Center

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative feedback from health providers	Nurses will be surveyed about their experience and perceptions of the technology	Once, at study completion
Primary	Nurse's response time to patients in distress	The time elapsed (in seconds) between the neoGuard alarm being triggered (distress signal) and the nurse attending to the patient	Captured in real time through monitor logs, within a few seconds to minutes of the event
Primary	Percentage of actionable alarms	The overall proportion of alarms that are indicative of a true physiological change (distress signal) resulting in an intervention or treatment of the patient	Measured over a maximum period of 7 days for each patient
Secondary	Incidence of patient complications	Bi-weekly change in the incidence of patient complications	Through study completion, across 64 weeks
Secondary	In-hospital mortality	Month-to-month change in the incidence of in-hospital mortality	Through study completion, across 16 months
Secondary	Frequency of key interventions	Month-to-month change in the frequency of key interventions administered (i.e., cPAP, supplemental oxygen, mechanical ventilation, antibiotic therapy)	Through study completion, across 16 months