Sudden Unexpected Postnatal Collapse -SUPCNCT07213401
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
A study testing ComfTech HOWDY BABY in people with Sudden Unexpected Postnatal Collapse -SUPC, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Sudden Unexpected Postnatal Collapse -SUPC
- What is being tested?
- ComfTech HOWDY BABY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age ³ 35 weeks
- Apgar score at 5 minutes ³ 8
- Acquisition of written informed consent from the parent/guardian
Who cannot join
- Major congenital malformations
- Family history of silver allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Irccs Aoubo
Bologna, BO, 40131
Luigi Tommaso Corvaglia, MD, 0512143691, luigi.corvaglia@unibo.it
About this study
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.
Read the 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.
- Being tested
- ComfTech HOWDY BABY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComfTech HOWDY BABYDevice
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 group | Role | What they receive |
|---|---|---|
| newborn | Other | 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. Receives: Device: ComfTech HOWDY BABY |
What is being measured
The primary outcome is the main question the study is designed to answer.
prodromal events of SUPC
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexpected Postnatal Collapse -SUPCStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213401
- Sponsor's protocol ID
- DARE_NEO_SUPC
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07213401
- Acronym / sponsor ID
- DARE_NEO_SUPC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborn | Other | Device: ComfTech HOWDY BABYThe 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. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age ³ 35 weeks
- Apgar score at 5 minutes ³ 8
- Acquisition of written informed consent from the parent/guardian
Key exclusion criteria (2 listed)
- Major congenital malformations
- Family history of silver allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComfTech HOWDY BABYThe 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. | Device | newborn |
Primary outcome
prodromal events of SUPC
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ComfTech HOWDY BABY in people with Sudden Unexpected Postnatal Collapse -SUPC, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Tommaso Corvaglia, MD (0512143691, luigi.corvaglia@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prodromal events of SUPC (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.