Pediatric Respiratory DistressNCT07370623
Development of an AI Assessment System for Pediatric Respiratory Distress : A Prospective Study
An observational study of Pediatric Respiratory Distress, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
This is a multicenter, prospective observational study designed to collect clinical data for the development of a vision-language model-based artificial intelligence system for automated assessment of pediatric respiratory patterns. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Pediatric Respiratory Distress
- How many people
- 2,200 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 28 Oct 2025to Dec 2027
- Phase
- Observational
- 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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients aged 0 to 12 years who visit the pediatric emergency departments of participating institutions. Clinical data, including basic demographic characteristics (e.g., sex, age, body weight, height), severity at presentation (e.g., KTAS level), vital signs, and emergency department management and outcomes (e.g., admission or discharge), as well as visual respiratory data, are collected during emergency care and used for the development and evaluation of a vision-language model-based system for automated assessment of pediatric respiratory patterns.
Who may be able to join
- Pediatric patients aged 0 to 12 years who present to participating pediatric emergency departments.
- Patients for whom clinical data, including basic demographic characteristics (e.g., age, body weight), severity at presentation (e.g., KTAS level), vital signs, emergency department management and outcomes, as well as visual respiratory data, are available during emergency care.
Who cannot join
- Patients outside the specified age range.
- Patients with insufficient or poor-quality clinical or visual respiratory data.
- Patients whose data cannot be used due to withdrawal of consent or regulatory restrictions.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
CHA Bundang Medical Center, CHA University, 9, Yatap-ro, Bundang-gu
Seongnam-si, Gyeonggi-do, 13496
Site Principal Investigator, 1577-4488, heartfeltdoctor@chamc.co.kr
- Recruiting
Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu
Seoul, Seoul, 05505
Site Principal Investigator, 1688-7575, mrmaran@naver.com
- Recruiting
Samsung Medical Center, 81, Irwon-ro, Gangnam-gu
Seoul, Seoul, 06351
SEJIN HEO, Principal Investigator, +82-2-3410-2053, silversh06@gmail.com
About this study
This is a multicenter, prospective observational study designed to collect clinical data for the development of a vision-language model-based artificial intelligence system for automated assessment of pediatric respiratory patterns.
The study enrolls pediatric patients aged 0 to 12 years who present to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics, including sex, age, body weight, height, presenting symptoms recorded at emergency department arrival, initial vital signs (body temperature, pulse rate, respiratory rate, blood pressure, and oxygen saturation), severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), emergency department management and outcomes such as hospital admission or discharge, and other relevant clinical information.
These data are used for cohort characterization and for the development and evaluation of an AI-based system that aims to automatically analyze pediatric respiratory patterns and support objective respiratory assessment in pediatric emergency care.
- Conditions
- Pediatric Respiratory Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Emergency Department Patients | Children aged 0 to 12 years presenting to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics (e.g., age, body weight, height), presenting symptoms, initial vital signs, severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), and emergency department management, and outcomes such as admission or discharge. All data are collected as part of routine clinical care and used for observational analysis and model development. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of automated respiratory pattern assessment
Performance of a vision-language model-based system in assessing pediatric respiratory patterns using clinical and visual respiratory data collected in pediatric emergency departments.
Measured: From study start through study completion (up to December 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start28 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370623
- Sponsor's protocol ID
- 2025-09-191
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an AI Assessment System for Pediatric Respiratory Distress : A Prospective Study
- ClinicalTrials.gov ID
- NCT07370623
- Acronym / sponsor ID
- 2025-09-191
- Conditions
- Pediatric Respiratory Distress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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 is a multicenter, prospective observational study designed to collect clinical data for the development of a vision-language model-based artificial intelligence system for automated assessment of pediatric respiratory patterns.
The study enrolls pediatric patients aged 0 to 12 years who present to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics, including sex, age, body weight, height, presenting symptoms recorded at emergency department arrival, initial vital signs (body temperature, pulse rate, respiratory rate, blood pressure, and oxygen saturation), severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), emergency department management and outcomes such as hospital admission or discharge, and other relevant clinical information.
These data are used for cohort characterization and for the development and evaluation of an AI-based system that aims to automatically analyze pediatric respiratory patterns and support objective respiratory assessment in pediatric emergency care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Emergency Department Patients | – | –Children aged 0 to 12 years presenting to the pediatric emergency departments of participating institutions. Clinical and visual respiratory data are collected along with baseline clinical characteristics (e.g., age, body weight, height), presenting symptoms, initial vital signs, severity at presentation assessed by the Korean Triage and Acuity Scale (KTAS), and emergency department management, and outcomes such as admission or discharge. All data are collected as part of routine clinical care and used for observational analysis and model development. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients aged 0 to 12 years who visit the pediatric emergency departments of participating institutions. Clinical data, including basic demographic characteristics (e.g., sex, age, body weight, height), severity at presentation (e.g., KTAS level), vital signs, and emergency department management and outcomes (e.g., admission or discharge), as well as visual respiratory data, are collected during emergency care and used for the development and evaluation of a vision-language model-based system for automated assessment of pediatric respiratory patterns.
Key inclusion criteria (2 listed)
- Pediatric patients aged 0 to 12 years who present to participating pediatric emergency departments.
- Patients for whom clinical data, including basic demographic characteristics (e.g., age, body weight), severity at presentation (e.g., KTAS level), vital signs, emergency department management and outcomes, as well as visual respiratory data, are available during emergency care.
Key exclusion criteria (3 listed)
- Patients outside the specified age range.
- Patients with insufficient or poor-quality clinical or visual respiratory data.
- Patients whose data cannot be used due to withdrawal of consent or regulatory restrictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of automated respiratory pattern assessment
Time frame: From study start through study completion (up to December 2027)
Performance of a vision-language model-based system in assessing pediatric respiratory patterns using clinical and visual respiratory data collected in pediatric emergency departments.
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 20 Mar 2026.
- 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.
CHA Bundang Medical Center, CHA University, 9, Yatap-ro, Bundang-gu
Seongnam-si, South Korea
Samsung Medical Center, 81, Irwon-ro, Gangnam-gu
Seoul, South Korea
3 sites 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 Distress, run by Samsung Medical Center at 3 sites in South Korea.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of automated respiratory pattern assessment (time frame: From study start through study completion (up to December 2027)). 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 20 Mar 2026.