Sudden Unexpected Postnatal Collapse -SUPC
Conditions
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 SUPC, thereby improving clinical practice.
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 neurological disabilities. To date, prevention of events is based on serial clinical monitoring of newborns during skin-to-skin contact. Some non-invasive monitoring systems integrated into wearable textiles have proven to be reliable and are well tolerated by newborns, families, and healthcare personnel. 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.
Interventions
DEVICEComfTech 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.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactLuigi Tommaso Corvaglia, MD
Outcome results
None listed