Eustachian Tube Growth and Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2018-08-24

Brief Summary

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This study is to measure over time (from 3 years until 13 years of age) Eustachian tube function (the way the Eustachian tube works) and facial growth in groups of children with two types of middle-ear disease and with little past middle-ear disease. These measures will be used to determine if facial growth is related to improved Eustachian tube function, to see if the better function explains why young children who have middle-ear disease outgrow it as they get older, and to determine if these measures are different for the children in the three groups defined by disease history.

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Detailed Description

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The existing literature documents an important role for the Eustachian tube (ET) in the pathogenesis and/or persistence of otitis media (OM). Cross-sectional studies report a lower prevalence of OM in older children, a better ET pressure-regulating function in older children and age-related differences in ET form, length and width, and the vector orientation of the paratubal musculature. These growth-related changes in ET structural relationships are demonstrably predictive of increasingly more efficient ET function (ETF) and, because the ET and paratubal musculature are intimately related to the cranial base, the vector orientation of the ET system can be reconstructed from osteological or radiographic data. Together, these observations suggest that measurable, age-related changes in ET-paratubal muscle vector relationships are reflected in more efficient ETF and, by consequence, a decreased OM risk. The overall goal of the proposed longitudinal study is to evaluate the validity of this hypothesis.

Conditions

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Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic otitis media with effusion (OME)

history of chronic effusion (3 months if both ears, 6 months if one ear, or 3 episodes of effusion each lasting for 2 months or longer)

No interventions assigned to this group

recurrent AOM

recurrent acute otitis media (3 episodes in 6 months or 4 episodes in 1 year)

No interventions assigned to this group

no OM

no history of significant otitis media (i.e., does not meet criteria for chronic OME or recurrent AOM)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 3 years of age
* History of middle ear disease must fit into one of the 3 categories of ear history
* With or without patent tympanostomy tubes at time of entry
* Generally good health

Exclusion Criteria

* Cleft palate or other syndromes predisposing to otitis
* History of significant orthodontic treatment or plan for such
* Cholesteatoma or other past ear surgery other than tubes
* Unable to cooperate for testing

Minimum Eligible Age

3 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes