Newborn MorbidityEarly Phase 1NCT04606589
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
A Early Phase 1 study testing neoGuard vital signs monitor in people with Newborn Morbidity and Newborn Complication, run by Neopenda, PBC at 1 site in Kenya.
Trial summary
The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Newborn Morbidity, Newborn Complication
- What is being tested?
- neoGuard vital signs monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteKenya
- Study dates
- 1 Feb 2021to 30 May 2021
- Phase
- Early Phase 1
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age <28 days
- Admitted to the neonatal intensive care unit
- Weight at birth/admission ≥2000 g
- Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
- Parent/guardian willing to provide informed consent for their newborn to participate in study
Who cannot join
- Age >28 days
- Has a condition that impairs them from wearing the device, such as hydrocephaly.
- Weight at birth <2000 g
- Very severe disease status (SICK score >2.4 at admission)
Trial locations and contacts
1 site in 1 country.
About this study
The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.
This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.
- Conditions
- Newborn Morbidity, Newborn Complication
- Being tested
- neoGuard vital signs monitor
- Keywords
- Newborn health, Newborn morbidity, Newborn critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoGuard vital signs monitorDevice
The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care | No intervention | The standard-of-care arm will receive intermittent monitoring of pulse rate and blood oxygen saturation with a conventional pulse oximeter. Temperature and respiratory rate will also be monitored intermittently with a digital thermometer and manual counting of breaths respectively. |
| neoGuard vital signs monitor | Experimental | The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device. Receives: Device: neoGuard vital signs monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital newborn mortality
Proportion of deaths that occur during hospital stay.
Measured: From date of admission to date of discharge or referral or death, up to 28 days
Secondary outcomes (2)
Complication rate
Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care.
Measured: From date of admission to date of discharge or referral or death, up to 28 days
Length of stay in hospital
Time elapsed between admission and discharge of a patient (measured in days).
Measured: From date of admission to date of discharge or referral or death, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Feb 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a simple pre/post interventional study model.
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neopenda, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Public Health and Development
- Responsible party
- Sponsor
- Investigators
- Bernard Olayo, MD, Principal investigator, Center for Public Health and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606589
- Sponsor's protocol ID
- MSU/DRPI/MUERC/00864/20
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 23 Mar 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
- ClinicalTrials.gov ID
- NCT04606589
- Acronym / sponsor ID
- MSU/DRPI/MUERC/00864/20
- Conditions
- Newborn Morbidity, Newborn Complication
- Keywords
- Newborn health, Newborn morbidity, Newborn critical care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Neopenda, PBCIndustry (pharma, biotech, devices)
- Collaborators
- Center for Public Health and Development
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 28 Oct 2020 (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 neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.
This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a simple pre/post interventional study model.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | No intervention | –The standard-of-care arm will receive intermittent monitoring of pulse rate and blood oxygen saturation with a conventional pulse oximeter. Temperature and respiratory rate will also be monitored intermittently with a digital thermometer and manual counting of breaths respectively. |
| neoGuard vital signs monitor | Experimental | Device: neoGuard vital signs monitorThe intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age <28 days
- Admitted to the neonatal intensive care unit
- Weight at birth/admission ≥2000 g
- Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
- Parent/guardian willing to provide informed consent for their newborn to participate in study
Key exclusion criteria (4 listed)
- Age >28 days
- Has a condition that impairs them from wearing the device, such as hydrocephaly.
- Weight at birth <2000 g
- Very severe disease status (SICK score >2.4 at admission)
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 neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns. | Device | neoGuard vital signs monitor |
Primary outcome
In-hospital newborn mortality
Time frame: From date of admission to date of discharge or referral or death, up to 28 days
Proportion of deaths that occur during hospital stay.
2 secondary outcomes
Complication rate
Time frame: From date of admission to date of discharge or referral or death, up to 28 days
Length of stay in hospital
Time frame: From date of admission to date of discharge or referral or death, up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Bernard Olayo, MD principal investigator
Center for Public Health and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing neoGuard vital signs monitor in people with Newborn Morbidity and Newborn Complication, run by Neopenda, PBC 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 23 Mar 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital newborn mortality (time frame: From date of admission to date of discharge or referral or death, up to 28 days). 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 23 Mar 2023.