Eustachian Tube Growth and Development

Completed

• Conditions: Otitis Media

• Registration Number: NCT00422929
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-17
• Primary Completion: 2017-01-16
• Study Completion: 2018-08-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in Eustachian tube function	5 years	Eustachian tube function is tested yearly from age 3 years through age 7 years

Secondary Outcome Measures

Name	Time	Method
change in craniofacial measures	5 years	cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years

Trial Locations

Locations (1)

ENT Research Center, Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States