Status:
RECRUITING
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Lead Sponsor:
Guilherme Sant'Anna, MD
Collaborating Sponsors:
Federal University of Uberlandia
University of Campinas, Brazil
Conditions:
Sudden Unexplained Infant Death
Apnea of Newborn
Eligibility:
All Genders
35-42 years
Phase:
NA
Brief 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 wee...
Detailed Description
When the transition from intrauterine to extrauterine life necessitates Neonatal Resuscitation, specialized monitoring of vital signs is required. Sudden Unexpected Postnatal Collapse (SUPC) is an apn...
Eligibility Criteria
Inclusion criteria:
- Newborns ≥35 weeks (gestational age)
- Newborns determined to be clinically stable at delivery
- Newborns with no skin abnormalities
Exclusion criteria:
- Newborns ≤ 35 weeks (gestational age)
- Newborns determined to not be clinically stable at delivery
- Newborns with Skin abnormalities
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06693817
Start Date
April 8 2025
End Date
June 30 2027
Last Update
April 17 2025
Active Locations (7)
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1
Hospitals Sanatorio Trinidad Palermo
Buenos Aires, Argentina
2
Hospital de Clínicas de Uberlândia
Umuarama, Minas Gerais, Brazil, 38405-320
3
ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM
São Paulo, Brazil
4
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1