Monitoring vital signs of newborns using advanced wireless sensors
Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 35 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 5 sites (Londrina, Paraná and 4 other locations) |
| Trial ID | NCT06693817 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates for this study are newborns who are at least 35 weeks gestational age and clinically stable at delivery.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Londrina, Paraná and 4 other locations
- Hospital Universitário da Universidade Estadual de Londrina — Londrina, Paraná, Brazil (Not_yet_recruiting)
- Montreal Children's Hospital — Montreal, Quebec, Canada (Recruiting)
- Royal Victoria Hospital — Montreal, Quebec, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.