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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Sudden Unexpected Postnatal Collapse -SUPC

Treatments: Device: ComfTech HOWDY BABY

Study type: Interventional

Funder types: Other

Identifiers

NCT07213401

DARE_NEO_SUPC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,000 participants in 1 patient group

newborn

Other group

Description:

The study population will consist of all babies born in the delivery room with a gestational age of ³35 weeks who are considered suitable for SSC in the first 2 hours of life and subsequently for rooming-in according to clinical practice.

Treatment:

Device: ComfTech HOWDY BABY