Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Recruiting
N/A
Interventional Study
Sudden Unexplained Infant Death
Apnea of Newborn
Newborn Morbidity
Newborn Asphyxia
Birth Outcome, Adverse
Birth Asphyxia
Pregnancy Related
Newborn; Vitality
ECG Electrode Site Reaction
Infant ALL
Infant Death
Infant, Newborn, Diseases
Infant Apnea
Infant Conditions
Parents
Delivery Problem for Fetus
Delivery Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 35 Weeks – 42 Weeks
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 600 (estimated)
- Sponsor
- Guilherme Sant'Anna, MD · Other
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About 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 feasibility
2. Evaluate safety
3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital…
Trial Locations
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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 wit…
Contacts