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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ComfTech HOWDY BABY.
- Who it may be relevant to
- Registry conditions: Sudden Unexpected Postnatal Collapse -SUPC. Basic parameters: up to 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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.
Primary outcome measures
- prodromal events of SUPC [Time frame: 72 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Irccs Aoubo — Bologna
Identifiers
NCT: NCT07213401 · DARE_NEO_SUPC