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Deep Learning–Based Noninvasive CT Imaging Model for Pediatric Protracted Bacterial Bronchitis: Development and Multicenter Validation

Deep Learning–Based Noninvasive CT Imaging Model for Pediatric Protracted Bacterial Bronchitis: Development and Multicenter Validation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111741
Enrollment
Unknown
Registered
2025-11-05
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protracted bacterial bronchitis (PBB)

Interventions

Gold Standard:Endoscopic purulent secretion plus positive BALF culture
Index test:An interpretable deep-learning model that automatically detects imaging signatures of pediatric protracted bacterial bronchitis (PBB) on high-resolution chest CT, achieving high agreement w

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.PBB Group (Protracted Bacterial Bronchitis Group) Inclusion Criteria: Participants in the PBB group must satisfy the following three conditions: (1) The diagnosis adheres to the "Microbiological Diagnostic Criteria" outlined in the Chinese Expert Consensus on the Diagnosis and Management of Chronic Wet Cough in Children (2019 Edition); (2) They underwent both CT scan and bronchoscopy after admission (with the CT scan required to be completed within 7 days prior to the bronchoscopy); and (3) Their age is under 18 years old. 2.Non-PBB Group Inclusion Criteria:Participants in the Non-PBB group must meet the following four criteria: (1) Matched with the PBB group in terms of age and sex; (2) No history of respiratory tract infection within the past three months; (3) Normal chest CT scan findings; and (4) No elevated complete blood count (CBC) to rule out potential subclinical inflammatory status. 3.External Validation Data: Inclusion criteria are the same as above.

Exclusion criteria

Exclusion criteria: 1.PBB Exclusion Criteria: Patients will be excluded from the PBB group if they meet any of the following conditions: (1) Chest imaging upon admission shows flocculent, patchy, linear, or punctate shadows in the lungs; (2) Co-infection with Mycoplasma, Bordetella pertussis, or tuberculosis; or (3) Co-existing severe cardiopulmonary or systemic diseases. 2.Non-PBB Group Exclusion Criteria:Patients will be excluded from the Non-PBB group if they meet either of the following conditions: (1) Chest CT examination shows **obvious flocculent, patchy, linear, or punctate shadows** in the lungs; or (2) **Recent history of respiratory symptoms. 3.External Validation Data: Exclusion criteria are the same as above.

Design outcomes

Primary

MeasureTime frame
Accuracy of imaging model for diagnosing PBB;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactDai Jihong

Children's Hospital of Chongqing Medical University

daniejh@163.com+86 23 6362 4074

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026