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

NCT ID: NCT07213401

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-06-30

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.

Conditions

Sudden Unexpected Postnatal Collapse -SUPC

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

newborn

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.

Group Type: OTHER

ComfTech HOWDY BABY

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Luigi Corvaglia

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Irccs Aoubo

Bologna, BO, Italy

Countries

Italy

Central Contacts

Luigi Tommaso Corvaglia, MD

Role: CONTACT

luigi.corvaglia@unibo.it

0512143691

Facility Contacts

Luigi Tommaso Corvaglia, MD

Role: primary

luigi.corvaglia@unibo.it

0512143691

Other Identifiers

DARE_NEO_SUPC

Identifier Type: -

Identifier Source: org_study_id