Status:
NOT_YET_RECRUITING
Non-invasive Monitoring of Newborns in the First Hours of Life for the Prevention of SUPC (Sudden Unexpected Postnatal Collapse): Interventional Study With Medical Device
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Sudden Unexpected Postnatal Collapse -SUPC
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
The application of non-invasive monitoring via a wearable device in newborns during the first 48-72 hours of life could enable early recognition and timely management of episodes that may result in SU...
Detailed Description
SUPC is a rare event, with maximum incidence in the first 2 hours of life of the newborn. Despite the rarity of events, the consequences can be dramatic, with a high risk of death and severe neurologi...
Eligibility Criteria
Inclusion
- Gestational age ³ 35 weeks
- Apgar score at 5 minutes ³ 8
- Acquisition of written informed consent from the parent/guardian
Exclusion
- Major congenital malformations
- Family history of silver allergy
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT07213401
Start Date
November 1 2025
End Date
June 30 2027
Last Update
October 8 2025
Active Locations (1)
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1
Irccs Aoubo
Bologna, BO, Italy, 40131