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Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Sponsor: Guilherme Sant'Anna, MD
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.
Official title: Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
Key Details
Gender
All
Age Range
35 Weeks - 42 Weeks
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-04-08
Completion Date
2027-06-30
Last Updated
2025-04-17
Healthy Volunteers
Yes
Conditions
Interventions
Wireless skin sensors vital sign monitoring system
The wireless monitoring system will be applied to the newborn and consist of a chest sensor (Anne Arc by Sibel Inc.) and a RAD-7 (Masimo)pulse oximeter limb sensor.
Wired vital sign monitoring system
A standard ECG and SpO2 monitoring device will be applied suing the Infinity M540 monitor (Draeger, Germany). The chest sensor will be placed as per standard of care on the newborn's chest and abdomen, and the SpO2 sensor on their hands or feet.
Locations (7)
Hospitals Sanatorio Trinidad Palermo
Buenos Aires, Argentina
Hospital de Clínicas de Uberlândia
Umuarama, Minas Gerais, Brazil
ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM
São Paulo, Brazil
Montreal Children's Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Maputo Central Hospital
Maputo, Mozambique
Mbuya Nehanda Hospital
Harare, Zimbabwe