NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room
| NCT ID | NCT06693817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guilherme Sant'Anna, MD |
| Condition | Sudden Unexplained Infant Death |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-04-08 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to: 1. Assess feasibility 2. Evaluate safety 3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.
Eligibility 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
Contact & Investigator
Guilherme Sant'Anna, MD, PhD
PRINCIPAL INVESTIGATOR
The Research institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT06693817 clinical trial?
This trial is open to participants of all sexes, aged 35 Weeks or older, up to 42 Weeks, studying Sudden Unexplained Infant Death. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06693817 currently recruiting?
Yes, NCT06693817 is actively recruiting participants. Contact the research team at guilherme.santanna@mcgill.ca for enrollment information.
Where is the NCT06693817 trial being conducted?
This trial is being conducted at Londrina, Brazil, Montreal, Canada, Montreal, Canada, Ponderano, Italy and 1 additional location.
Who is sponsoring the NCT06693817 clinical trial?
NCT06693817 is sponsored by Guilherme Sant'Anna, MD. The principal investigator is Guilherme Sant'Anna, MD, PhD at The Research institute of the McGill University Health Centre. The trial plans to enroll 600 participants.