Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room (NCT07739810) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
5 participantsStarted 2026-09-01
Plain-language 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. 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.
Who can participate
Age range
24 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Electrocardiography (ECG) Accuracy
Timeframe: During two 15-minute monitoring periods within the first 90 minutes after birth
2
Skin Temperature Accuracy
Timeframe: During two 15-minute monitoring periods within the first 90 minutes after birth.
3
Oxygen Saturation (SpO₂) Accuracy
Timeframe: During two 15-minute monitoring periods within the first 90 minutes after birth.
Trial details
NCT IDNCT07739810
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre