Which mediators of inflammation and which factors of gastro-oesophageal reflux are present in middle ear effusion? Can the findings of this study attribute to pharmacological treatment of OME.
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analysis of middle ear effusion for mediators of inflammation and factors of
gastro-oesophageal reflux.
Secondary outcome
NA
Background summary
Otitis media with effusion (OME) is one of the most common diseases in
children. The duration of OME can vary. In persistent OME the hearing loss can
result in an impaired development of speech, language, communicative and
cognitive skills and parent-child interactions.
The pathogenesis of OME is multifactorial. Hypoventilation of the middle ear
plays a central role. It seems that upper airway infections, allergy and
gastro-oesophageal reflux are also involved.
The treatment of OME consists of watchful waiting or surgery with the placement
of ventilation tubes. Ventilation tubes result in an alternative way of middle
ear ventilation with resolution of the effusion from the middle ear, placement
of ventilation tubes does not cure the primary cause. There is considerable
disagreement about the indication for placement of ventilation tubes.
Nevertheless, each year about 50.000 children are treated with ventilation
tubes, with substantial regional differences.
Therefore, there is a clear indication for further research into wich factors
are involved in the chronic inflammatory reactions in the middle ear mucosa,
attributing to the production of mucus. This research can improve the
indication for treating OME with ventilation tubes, with pharmacological
treatment as a possible alternative.
Study objective
Which mediators of inflammation and which factors of gastro-oesophageal reflux
are present in middle ear effusion? Can the findings of this study attribute to
pharmacological treatment of OME.
Study design
Before placement of a ventilation tube the effusion is evacuated from the
middle ear and collected. The effusions are analysed for acidity, bacteriology,
mediators of inflammation and factors of gastro-oesophageal reflux.
Study burden and risks
Collection of middle ear fluid takes a few minutes only. The surgical procedure
is hardly lengthened, there are no risks and the post-operative course is not
affected.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
otitis media with effusion
Exclusion criteria
cleft palate
Down syndrome
immunological disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37924.018.11 |