Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
Guilherme Sant'Anna, MD
600 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Newborns ≥35 weeks (gestational age)
- Newborns determined to be clinically stable at delivery
- Newborns with no skin abnormalities
Exclusion Criteria3
- Newborns ≤ 35 weeks (gestational age)
- Newborns determined to not be clinically stable at delivery
- Newborns with Skin abnormalities
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Interventions
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.
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)
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NCT06693817