Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department

NCT04752891 | Completed

• 1 other identifier: 20-HPNCL-07
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

Conditions

Otitis Media, Suppurative

Outcome Measures

Primary Outcomes (2)

• diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®

  diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle).

  at inclusion

• diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope

  diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle)

  at inclusion

Secondary Outcomes (3)

• rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application

  at inclusion

• collection risk factors for a discrepancy in the diagnosis of purulent AOM

  at inclusion

• satisfaction of junior physicians regarding the use of the app

  through study completion, an average of 1 year

Study Arms (2)

AOM diagnosis with app

EXPERIMENTAL

Other: AOM diagnosis with app

AOM diagnosis without app

OTHER

Other: AOM diagnosis without app

Interventions

AOM diagnosis with app OTHER

the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone

AOM diagnosis with app

AOM diagnosis without app OTHER

the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

AOM diagnosis without app

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained

You may not qualify if:

• A sign (s) of vital distress Trans-tympanic drains

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, France

Location

MeSH Terms

Conditions

Otitis Media, Suppurative

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Suppuration; Infections; Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: June 10, 2021
• Primary Completion: August 16, 2022
• Study Completion: March 16, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

FR (1)