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

Recruiting

• Conditions: Newborn Complication; Newborn Morbidity
• Interventions: Device: neoGuard vital signs monitor

• Registration Number: NCT05728307
• Lead Sponsor: Assumpta Solome Nantume

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. 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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-28
• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-11
• Study First Posted: 2023-02-15
• Primary Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	neoGuard vital signs monitor	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).

Primary Outcome Measures

Name	Time	Method
Nurse's response time to patients in distress	Captured in real time through monitor logs, within a few seconds to minutes of the event	The time elapsed (in seconds) between the neoGuard alarm being triggered (distress signal) and the nurse attending to the patient
Percentage of actionable alarms	Measured over a maximum period of 7 days for each patient	The overall proportion of alarms that are indicative of a true physiological change (distress signal) resulting in an intervention or treatment of the patient

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Through study completion, across 16 months	Month-to-month change in the incidence of in-hospital mortality
Incidence of patient complications	Through study completion, across 64 weeks	Bi-weekly change in the incidence of patient complications
Frequency of key interventions	Through study completion, across 16 months	Month-to-month change in the frequency of key interventions administered (i.e., cPAP, supplemental oxygen, mechanical ventilation, antibiotic therapy)

Trial Locations

Locations (1)

Moi Teaching and Referral Hospital; 🇰🇪 Eldoret, Kenya