Clinical trial NCT05728307: Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
Official title: Evaluating the Clinical Impact and Cost-effectiveness of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newborn Complication
Newborn Morbidity
Keywords: Vital signs monitoring
Health technology
Medical device
Wearable device
Lead sponsor: Neopenda, PBC
Sponsor class: INDUSTRY
Collaborators: name: Academic Model Providing Access to Healthcare (AMPATH)
name: DLR German Aerospace Center
First posted: 2023-02-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nurse's response time to patients in distress
timeFrame: Captured in real time through monitor logs, within a few seconds to minutes of the event
measure: Percentage of actionable alarms
timeFrame: Measured over a maximum period of 7 days for each patient
Secondary outcomes:
measure: Incidence of patient complications
timeFrame: Through study completion, across 64 weeks
measure: In-hospital mortality
timeFrame: Through study completion, across 16 months
measure: Frequency of key interventions
timeFrame: Through study completion, across 16 months
Other outcomes:
measure: Qualitative feedback from health providers
timeFrame: Once, at study completion
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
affiliation: Moi Teaching and Referral Hospital/Moi University
name: Festus Njuguna, MMed
role: PRINCIPAL_INVESTIGATOR
References: