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Advanced Wireless Sensors for Neonatal Care in the Delivery Room

RecruitingNAAges 35 Weeks - 42 WeeksAllGuilherme Sant'Anna, MD
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Wireless skin sensors vital sign monitoring system
  • Wired vital sign monitoring system
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Where

5 sites
Hospital Universitário da Universidade Estadual de Londrina
Londrina, Brazil
Montreal Children's Hospital
Montreal, Canada
Royal Victoria Hospital
Montreal, Canada
Nuovo Ospedale degli Infermi
Ponderano, Italy
Lucerne Cantonal Hospital
Lucerne, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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