Wireless Sensors for Neonatal Care
(AWARD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial is for newborns and does not mention any medication requirements for participants.
What data supports the effectiveness of the treatment Wireless skin sensors vital sign monitoring system?
Is the wireless sensor system for neonatal care safe for use in humans?
How does the wireless skin sensors vital sign monitoring system differ from other treatments for neonatal care?
The wireless skin sensors for neonatal care are unique because they are soft, ultrathin, and operate without wires or batteries, reducing the risk of skin damage and allowing for better parent-infant interaction. Unlike traditional systems, these sensors provide continuous, real-time monitoring of vital signs with additional features like movement tracking and acoustic monitoring, all while being gentle on the baby's skin.12347
What is the purpose of this trial?
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 feasibility2. Evaluate safety3. 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.
Research Team
Guilherme Sant'Anna, MD, PhD
Principal Investigator
The Research institute of the McGill University Health Centre
Eligibility Criteria
This trial is for healthy newborns born at or after 35 weeks of pregnancy. It aims to see if a new wireless sensor system can track their vital signs right after birth and during the first two hours under unsupervised parental care.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Monitoring
Newborns are monitored using both wireless and wired vital sign monitoring systems immediately after delivery for 2 hours
Follow-up
Participants are monitored for safety and effectiveness after the initial monitoring period
Treatment Details
Interventions
- Wireless skin sensors vital sign monitoring system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Guilherme Sant'Anna, MD
Lead Sponsor
University of Campinas, Brazil
Collaborator
Sanatorio de la Trinidad Palermo
Collaborator
Federal University of Uberlandia
Collaborator
Mbuya Nehanda Hospital Harare Zimbabwe
Collaborator
Hopsital Central de Maputo, Mozambique
Collaborator