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

NCT03611842 | Completed

• 1 other identifier: RECHMPL18_0306
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

• Microscopic evaluation of the quality of the eardrum : normal or atrophic

  Microscopic evaluation of the quality of the eardrum : normal or atrophic

  before surgery

Secondary Outcomes (2)

• biochemical assay of the level of TIMP

  1 day

• biochemical assay of the level of MMPs

  1 day

Study Arms (2)

Healthy eardrum

OME (otitis media with effusion)with normal tympanic membrane

Other: preservation of mucosal otitis media

Atrophic eardrum

OME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket

Other: preservation of mucosal otitis media

Interventions

preservation of mucosal otitis media OTHER

Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum

Atrophic eardrum; Healthy eardrum

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children under the age of twelve with OME and surgical indication for myringostomy of tube placement

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INM : institut des neurosciences Montpellier: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Middle ear effusion fluids

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Lylou Casteil Baume, ENT resident

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: September 30, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 30, 2018
• Last Updated: April 19, 2019

Record last verified: 2018-07

Locations

FR (1)