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

NCT05728307 | Unknown

• 1 other identifier: FAN:0003994
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
2. 2.Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
3. 3.Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
4. 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).

Conditions

Newborn Complication; Newborn Morbidity

Keywords

Vital signs monitoring; Health technology; Medical device; Wearable device

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Incidence of patient complications

  Through study completion, across 64 weeks

• In-hospital mortality

  Through study completion, across 16 months

• Frequency of key interventions

  Through study completion, across 16 months

Other Outcomes (1)

• Qualitative feedback from health providers

  Once, at study completion

Study Arms (2)

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).

Device: neoGuard vital signs monitor

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.

Interventions

neoGuard vital signs monitor DEVICE

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).

Intervention Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of newborns aged 0-28 days admitted to the neonatal ward at MTRH between April 2022-June 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assumpta Solome Nantume: lead
• Academic Model Providing Access to Healthcare (AMPATH): collaborator
• DLR German Aerospace Center: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

RECRUITING

Study Officials

• Festus Njuguna, MMed

  Moi Teaching and Referral Hospital/Moi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assumpta S Nantume, MSc

CONTACT

2037472391; assumpta@neopenda.com

Joseph K Kirui, MSc

CONTACT

254720393547; jkirui@ampath.or.ke

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research & Evaluation Lead

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 15, 2023
• Study Start: November 28, 2022
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)