Monitoring vital signs of newborns using advanced wireless sensors
Official title: Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06693817 · Data updated 2026-11-12
This study is testing a new wireless sensor to see if it can safely and accurately monitor the vital signs of healthy newborns during their first two hours after birth compared to the traditional wired system.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Weeks to 42 Weeks |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 5 sites (Londrina, Paraná and 4 other locations) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | July 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT06693817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are newborns who are at least 35 weeks gestational age and clinically stable at delivery.
✕Probably not a fit
Patients who may not benefit from this study include those born before 35 weeks gestational age or those who are not clinically stable at delivery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the feasibility, safety, and accuracy of a new wireless skin sensor system for monitoring vital signs in healthy newborns (≥ 35 weeks gestational age) during the first two hours after delivery. The study will compare the wireless monitoring system to the standard wired system while the newborns are under unsupervised parental care in the obstetrical center. Both monitoring systems will be placed on the infants' chest and limb to continuously track heart rate, oxygen saturation, and skin temperature. The goal is to improve neonatal care and reduce the risk of Sudden Unexpected Postnatal Collapse (SUPC).
Why it matters
Potential benefit: If successful, this study could enhance the safety and monitoring of newborns immediately after birth, potentially reducing the incidence of neonatal complications.
How similar studies have gone: While the use of wireless monitoring technology is gaining traction, this specific approach to monitor vital signs in newborns immediately after delivery is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Newborns ≥35 weeks (gestational age) 2. Newborns determined to be clinically stable at delivery 3. Newborns with no skin abnormalities Exclusion criteria: 1. Newborns ≤ 35 weeks (gestational age) 2. Newborns determined to not be clinically stable at delivery 3. Newborns with Skin abnormalities
Where it's running
-
Montreal Children's Hospital
Montreal, Quebec, Canada Recruiting -
Royal Victoria Hospital
Montreal, Quebec, Canada Recruiting -
Hospital Universitário da Universidade Estadual de Londrina
Londrina, Paraná, Brazil Not yet recruiting -
Nuovo Ospedale degli Infermi
Ponderano, Bi, Italy Not yet recruiting -
Lucerne Cantonal Hospital
Lucerne, Canton of Lucerne, Switzerland Not yet recruiting
Study contacts
- Principal investigator: Guilherme Sant'Anna, MD, PhD — The Research institute of the McGill University Health Centre
- Study coordinator: Guilherme Sant´Anna, MD, PhD
- Email: guilherme.santanna@mcgill.ca
- Phone: 514-934-1934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.