Neonatal BradycardiaBRADY-INCT05774470
Bradycardia Recognition and Detection in Young Infants Part-I
An observational study of Neonatal Bradycardia and Hypoxemia of Newborn, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Neonatal Bradycardia, Hypoxemia of Newborn
- What is being tested?
- Owlet OSS 3.0
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2023to 29 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 365 days
- All sexes
- Child
Study population: Infants admitted to the neonatal intensive care unit.
Who may be able to join
- Off ventilatory support/NCPAP/HFNC and phototherapy for > 48 hours
- Less than one-year corrected age
- Current weight >1500 grams
- Parents/legal guardians have provided consent for enrollment
Who cannot join
- a major malformation
- a neuromuscular condition that affects respiration or causes apnea
- active skin breakdown or skin infection
- terminal illness or decision to withhold or limit support
- We will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bradycardia Recognition and Detection in Young Infants Using the Owlet OSS 3.0 Monitor (Brady-I Study)
This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.
Read the detailed description
We will attach an Owlet monitor to infants for a 48-hour period. We will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. In addition, we will collect simultaneous high-resolution real time cardiorespiratory data from Philips MP70 patient monitors at the University of Alabama at Birmingham.
- Conditions
- Neonatal Bradycardia, Hypoxemia of Newborn
- Being tested
- Owlet OSS 3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owlet OSS 3.0Device
The Owlet OSS 3.0 is a non-invasive monitoring device. The Sock secures the Sensor to the baby's foot. The Sensor measures the baby's SpO2, heart rate, and movement, and transmits the baby's readings to the Base Station. The Base Station records and monitors the baby's readings and can indicate prompts as needed based on the data sent from the Sensor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia and/or hypoxemia
The diagnostic accuracy of the Owlet OSS 3.0 monitor for detection of bradycardia <50/min and/or hypoxemia with SpO2 <80% episodes for ≥3 seconds during a 48-hour period.
Measured: 48 hours
Secondary outcomes (4)
Bradycardia episodes
The diagnostic accuracy of the Owlet OSS 3.0 monitor for episodes of bradycardia using alternative definitions of depth and duration (<50/min; < 80/min; < 100/min; lasting ≥ 10 seconds; lasting ≥ 20 seconds).
Measured: 48 hours
Hypoxemia episodes
The diagnostic accuracy of episodes of intermittent hypoxemia of different severity and duration (<80%; <85%; lasting ≥ 10 seconds; lasting ≥ 20 seconds).
Measured: 48 hours
Diagnostic accuracy
The false alarm rate and other key measures of diagnostic accuracy.
Measured: 48 hours
Limits of agreement
The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 Apr 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal BradycardiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774470
- Sponsor's protocol ID
- 300010237
- Acronym
- BRADY-I
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Travers CP, Nakhmani A, Armstead KM, Benz RL, Foshee KM, Carlo WA. Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events. Arch Dis Child Fetal Neonatal Ed. 2025 Dec 15;111(1):F13-F19. doi: 10.1136/archdischild-2025-328540.
PubMed 40355254
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bradycardia Recognition and Detection in Young Infants Using the Owlet OSS 3.0 Monitor (Brady-I Study)
- ClinicalTrials.gov ID
- NCT05774470
- Acronym / sponsor ID
- BRADY-I / 300010237
- Conditions
- Neonatal Bradycardia, Hypoxemia of Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 17 Mar 2023 (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.
This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.
Detailed description
We will attach an Owlet monitor to infants for a 48-hour period. We will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. In addition, we will collect simultaneous high-resolution real time cardiorespiratory data from Philips MP70 patient monitors at the University of Alabama at Birmingham.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Age groups
- Child
- Study population
- Infants admitted to the neonatal intensive care unit.
Key inclusion criteria (4 listed)
- Off ventilatory support/NCPAP/HFNC and phototherapy for > 48 hours
- Less than one-year corrected age
- Current weight >1500 grams
- Parents/legal guardians have provided consent for enrollment
Key exclusion criteria (5 listed)
- a major malformation
- a neuromuscular condition that affects respiration or causes apnea
- active skin breakdown or skin infection
- terminal illness or decision to withhold or limit support
- We will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.
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 |
|---|---|---|
| Owlet OSS 3.0The Owlet OSS 3.0 is a non-invasive monitoring device. The Sock secures the Sensor to the baby's foot. The Sensor measures the baby's SpO2, heart rate, and movement, and transmits the baby's readings to the Base Station. The Base Station records and monitors the baby's readings and can indicate prompts as needed based on the data sent from the Sensor. | Device | – |
Primary outcome
Bradycardia and/or hypoxemia
Time frame: 48 hours
The diagnostic accuracy of the Owlet OSS 3.0 monitor for detection of bradycardia <50/min and/or hypoxemia with SpO2 <80% episodes for ≥3 seconds during a 48-hour period.
4 secondary outcomes
Bradycardia episodes
Time frame: 48 hours
Hypoxemia episodes
Time frame: 48 hours
Diagnostic accuracy
Time frame: 48 hours
Limits of agreement
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 40355254Travers CP, Nakhmani A, Armstead KM, Benz RL, Foshee KM, Carlo WA. Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events. Arch Dis Child Fetal Neonatal Ed. 2025 Dec 15;111(1):F13-F19. doi: 10.1136/archdischild-2025-328540.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Colm P Travers, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Bradycardia and Hypoxemia of Newborn, run by University of Alabama at Birmingham at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bradycardia and/or hypoxemia (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774470, which also lists 1 linked publication.
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 15 Mar 2024.