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Clinical Trials in Italy / NCT07213401
Starting soon Not applicable

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

NCT07213401 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Not applicable
Started
2025-11-01
Last updated
2025-10-08

Condition(s) studied

Sudden Unexpected Postnatal Collapse -SUPC

Investigational drug(s) / intervention(s)

ComfTech HOWDY BABY

ComfTech HOWDY BABY: The Comftech HOWDYBABY medical device is a device for monitoring vital physiological parameters, in particular for monitoring heart rate and respiratory rate, consisting of a sensor-equipped belt. Blood oxygen saturation can also be monitored using a compatible accessory.

Study 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 SUPC, thereby improving clinical practice.

Eligibility

Sex
ALL
Min age
—
Max age
3 Days
Healthy volunteers
Accepted
Inclusion Criteria: * Gestational age ³ 35 weeks * Apgar score at 5 minutes ³ 8 * Acquisition of written informed consent from the parent/guardian Exclusion Criteria: * Major congenital malformations * Family history of silver allergy

Primary outcome measure(s)

  • prodromal events of SUPC — 72 hours
    Measure how many prodromal events of SUPC (bradycardia, bradypnea, apnea) are detected with the ComfTech HOWDY BABY device (ComfTech S.r.l.), outside the times scheduled for clinical monitoring in the first 72 hours of life of newborns.

Trial sites (1)

FacilityCityRegionStatus
Irccs Aoubo Bologna BO

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213401 on ClinicalTrials.gov ↗ ← All trials in Italy