Newborn ComplicationNCT05728307
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
An observational study of Newborn Complication and Newborn Morbidity, run by Assumpta Solome Nantume at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Newborn Complication, Newborn Morbidity
- What is being tested?
- neoGuard vital signs monitor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 3,000 participants
- Where
- 1 siteKenya
- Study dates
- 28 Nov 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of newborns aged 0-28 days admitted to the neonatal ward at MTRH between April 2022-June 2023.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Moi Teaching and Referral Hospital
Eldoret
Audrey Chepkemoi, MMed, audreychepkemoi@gmail.com
Leah Mukuhi, BSN, 254759899674, leahmukuhi@gmail.com
About this study
Official title: Evaluating the Clinical Impact and Cost-effectiveness of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
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:
- Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
- Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
- Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
- 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.
Read the 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.
- Conditions
- Newborn Complication, Newborn Morbidity
- Being tested
- neoGuard vital signs monitor
- Keywords
- Vital signs monitoring, Health technology, Medical device, Wearable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoGuard vital signs monitorDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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: Measured over a maximum period of 7 days for each patient
Secondary outcomes (3)
Incidence of patient complications
Bi-weekly change in the incidence of patient complications
Measured: Through study completion, across 64 weeks
In-hospital mortality
Month-to-month change in the incidence of in-hospital mortality
Measured: Through study completion, across 16 months
Frequency of key interventions
Month-to-month change in the frequency of key interventions administered (i.e., cPAP, supplemental oxygen, mechanical ventilation, antibiotic therapy)
Measured: Through study completion, across 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start28 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assumpta Solome Nantume
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH), DLR German Aerospace Center
- Responsible party
- Sponsor-investigator, Assumpta Solome Nantume, Neopenda, PBC
- Investigators
- Festus Njuguna, MMed, Principal investigator, Moi Teaching and Referral Hospital/Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728307
- Sponsor's protocol ID
- FAN:0003994
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Impact and Cost-effectiveness of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
- ClinicalTrials.gov ID
- NCT05728307
- Acronym / sponsor ID
- FAN:0003994
- Conditions
- Newborn Complication, Newborn Morbidity
- Keywords
- Vital signs monitoring, Health technology, Medical device, Wearable device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Assumpta Solome NantumeIndustry (pharma, biotech, devices)
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH), DLR German Aerospace Center
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
- Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
- Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Device: neoGuard vital signs monitorThe 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). |
| 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of newborns aged 0-28 days admitted to the neonatal ward at MTRH between April 2022-June 2023.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoGuard vital signs monitorThe 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). | Device | Intervention Group |
Primary outcome
Nurse's response time to patients in distress
Time frame: 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
Time frame: 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
3 secondary outcomes
Incidence of patient complications
Time frame: Through study completion, across 64 weeks
In-hospital mortality
Time frame: Through study completion, across 16 months
Frequency of key interventions
Time frame: Through study completion, across 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Festus Njuguna, MMed principal investigator
Moi Teaching and Referral Hospital/Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Complication and Newborn Morbidity, run by Assumpta Solome Nantume at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assumpta S Nantume, MSc (2037472391, assumpta@neopenda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurse's response time to patients in distress (time frame: Captured in real time through monitor logs, within a few seconds to minutes of the event). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.