Development of an AI Assessment System for Pediatric Respiratory Distress : A Prospective 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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Respiratory Distress

• Study Type: Observational
• Enrollment (Estimated): 2200

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • Recruiting
      • CHA Bundang Medical Center, CHA University, 9, Yatap-ro, Bundang-gu
      • Contact: Site Principal Investigator; Phone Number: 1577-4488; Email: heartfeltdoctor@chamc.co.kr
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center, 81, Irwon-ro, Gangnam-gu
      • Contact: SEJIN HEO, Principal Investigator; Phone Number: +82-2-3410-2053; Email: silversh06@gmail.com
    • Seoul, Seoul, South Korea, 05505
      • Recruiting
      • Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu
      • Contact: Site Principal Investigator; Phone Number: 1688-7575; Email: mrmaran@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From study start through study completion (up to December 2027)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-09-191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO