Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum

Completed

• Conditions: Otitis Media With Effusion
• Interventions: Other: preservation of mucosal otitis media

• Registration Number: NCT03611842
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

Detailed Description

The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Study Start: 2018-09-30
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-30
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria:

• when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrophic eardrum	preservation of mucosal otitis media	OME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket
Healthy eardrum	preservation of mucosal otitis media	OME (otitis media with effusion)with normal tympanic membrane

Primary Outcome Measures

Name	Time	Method
Microscopic evaluation of the quality of the eardrum : normal or atrophic	before surgery	Microscopic evaluation of the quality of the eardrum : normal or atrophic

Secondary Outcome Measures

Name	Time	Method
biochemical assay of the level of MMPs	1 day	biochemical assay of the level of MMPs
biochemical assay of the level of TIMP	1 day	biochemical assay of the level of TIMP

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France