Pediatric Respiratory DiseasesNCT05661422
Analysis of Lung Sounds Collected by RESP Biosensor to Support Decision Making in Monitored Hospitalized Pediatric Patients
An observational study of Pediatric Respiratory Diseases and Asthma, run by Strados Labs, Inc. at 1 site in United States.
Trial summary
This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pediatric Respiratory Diseases, Asthma, RSV Infection
- What is being tested?
- RESP™ Biosensor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Dec 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric subjects who are admitted to the hospital with respiratory disease, including exacerbation of chronic respiratory disease and infection of RSV or COVID-19
Who may be able to join
- Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
- Hospitalization projected for at least 24 hours after device placement
- Patient and parent/guardian able and willing to provide informed consent/assent.
Who cannot join
- Patient and parent/guardian unable or unwilling to provide informed consent
- Patient expected to undergo prolonged invasive radiology procedure(s)
- Plan for discharge within 24 hours
- Patient expected to undergo major thoracic surgery
- History of adverse reaction or allergy to TegaDerm ® or similar product
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Health University Medical Center
Savannah, Georgia, 31404
About this study
Official title: Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients
This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.
- Conditions
- Pediatric Respiratory Diseases, Asthma, RSV Infection, COVID-19
- Being tested
- RESP™ Biosensor
- Medical subject headings
- Asthma, Respiratory Syncytial Virus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP™ BiosensorDevice
Also called RESP
The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Not described Receives: Device: RESP™ Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualification and verification of lung sounds in pediatric population using RESP Biosensor
Measured: Periodic recording over 24 hours for inpatient stay
Secondary outcomes (2)
Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families
Measured: Periodic recording over 24 hours for inpatient stay
Limitations such as age in pediatric patients
Measured: Periodic recording over 24 hours for inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Sponsor Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Respiratory DiseasesStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strados Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661422
- Sponsor's protocol ID
- SL-MHUMC01
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients
- ClinicalTrials.gov ID
- NCT05661422
- Acronym / sponsor ID
- SL-MHUMC01
- Conditions
- Pediatric Respiratory Diseases, Asthma, RSV Infection, COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor Hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Strados Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Dec 2022 (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 observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: RESP™ Biosensor |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric subjects who are admitted to the hospital with respiratory disease, including exacerbation of chronic respiratory disease and infection of RSV or COVID-19
Key inclusion criteria (3 listed)
- Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
- Hospitalization projected for at least 24 hours after device placement
- Patient and parent/guardian able and willing to provide informed consent/assent.
Key exclusion criteria (5 listed)
- Patient and parent/guardian unable or unwilling to provide informed consent
- Patient expected to undergo prolonged invasive radiology procedure(s)
- Plan for discharge within 24 hours
- Patient expected to undergo major thoracic surgery
- History of adverse reaction or allergy to TegaDerm ® or similar product
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 |
|---|---|---|
| RESP™ BiosensorAlso: RESPThe RESP Biosensor will be placed on the patient for periodic recording of auscultory sound. | Device | Participants |
Primary outcome
Qualification and verification of lung sounds in pediatric population using RESP Biosensor
Time frame: Periodic recording over 24 hours for inpatient stay
2 secondary outcomes
Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families
Time frame: Periodic recording over 24 hours for inpatient stay
Limitations such as age in pediatric patients
Time frame: Periodic recording over 24 hours for inpatient stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Respiratory Diseases
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingPhase 3
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Influenza
Not yet recruitingObservational study
Neutrophil Monocyte Lymphocyte Ratios in Pediatric Chest Infections
Pneumonia, Bronchiolitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Respiratory Diseases and Asthma, run by Strados Labs, Inc. 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 3 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: withdrawn, as of the sponsor's last update on 16 Mar 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Qualification and verification of lung sounds in pediatric population using RESP Biosensor (time frame: Periodic recording over 24 hours for inpatient stay). 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 16 Mar 2023.