Vital Signs MonitoringNCT07739810
Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
An observational study of Vital Signs Monitoring and Newborn Monitoring, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Vital Signs Monitoring, Newborn Monitoring, Physiologic Monitoring
- What is being tested?
- Wireless MicroPremVitals Button Sensor
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy newborn infants in the delivery room at the study site who are eligible for routine delivery room monitoring and whose parent(s) or legal guardian provide informed consent for study participation.
Who may be able to join
- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Who cannot join
- Infants with skin abnormality would potentially increase the risk of injury.
- Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment.
- Infants born at <35 weeks gestational age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.
- Being tested
- Wireless MicroPremVitals Button Sensor
- Keywords
- Wireless monitoring, Vital signs, Newborn, Neonate, Delivery room, Wearable sensor, Electrocardiography, Respiratory rate, Skin temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless MicroPremVitals Button SensorDevice
A wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature. Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Newborn Infants | Healthy newborn infants enrolled in the study who will undergo simultaneous monitoring with the Wireless MicroPremVitals Button Sensor System and standard-of-care monitoring in the delivery room to evaluate the accuracy, safety, and feasibility of the wireless monitoring system. Receives: Device: Wireless MicroPremVitals Button Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiography (ECG) Accuracy
Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Measured: During two 15-minute monitoring periods within the first 90 minutes after birth
Skin Temperature Accuracy
Agreement between skin temperature measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Measured: During two 15-minute monitoring periods within the first 90 minutes after birth.
Oxygen Saturation (SpO₂) Accuracy
Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Measured: During two 15-minute monitoring periods within the first 90 minutes after birth.
Secondary outcomes (2)
Heart Rate Accuracy
Heart rate will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System. Agreement between calculated heart rate and the standard-of-care Dräger Infinity M540 monitor will be evaluated.
Measured: During two 15-minute monitoring periods within the first 90 minutes after birth.
Heart Rate Variability (HRV)
Heart rate variability will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System. Derived HRV measurements will be compared with HRV derived from the standard-of-care Dräger Infinity M540 monitor.
Measured: During two 15-minute monitoring periods within the first 90 minutes after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Signs MonitoringStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme Sant'Anna, MD, PhD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739810
- Sponsor's protocol ID
- Button Sensors in the DR
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
- ClinicalTrials.gov ID
- NCT07739810
- Acronym / sponsor ID
- Button Sensors in the DR
- Keywords
- Wireless monitoring, Vital signs, Newborn, Neonate, Delivery room, Wearable sensor, Electrocardiography, Respiratory rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn Infants | – | Device: Wireless MicroPremVitals Button SensorHealthy newborn infants enrolled in the study who will undergo simultaneous monitoring with the Wireless MicroPremVitals Button Sensor System and standard-of-care monitoring in the delivery room to evaluate the accuracy, safety, and feasibility of the wireless monitoring system. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy newborn infants in the delivery room at the study site who are eligible for routine delivery room monitoring and whose parent(s) or legal guardian provide informed consent for study participation.
Key inclusion criteria (1 listed)
- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Key exclusion criteria (3 listed)
- Infants with skin abnormality would potentially increase the risk of injury.
- Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment.
- Infants born at <35 weeks gestational age.
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 |
|---|---|---|
| Wireless MicroPremVitals Button SensorA wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature. Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making. | Device | Newborn Infants |
Primary outcome
Electrocardiography (ECG) Accuracy
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth
Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Skin Temperature Accuracy
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
Agreement between skin temperature measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Oxygen Saturation (SpO₂) Accuracy
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
2 secondary outcomes
Heart Rate Accuracy
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
Heart Rate Variability (HRV)
Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- 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.
Guilherme Sant'Anna, MD, PhD principal investigator
RI-MUHC
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs Monitoring and Newborn Monitoring, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Maximov, BSc. (5149341934 ext. 78229, alyssa.maximov@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiography (ECG) Accuracy (time frame: During two 15-minute monitoring periods within the first 90 minutes after birth). The study lists 3 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 31 Jul 2026.