Overview

This trial is active, not recruiting.

Condition otitis media
Sponsor University of Pittsburgh
Collaborator National Institute on Deafness and Other Communication Disorders (NIDCD)
Start date August 2006
End date July 2018
Trial size 150 participants
Trial identifier NCT00422929, #0605009, 5P50DC007667-06

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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)
recurrent acute otitis media (3 episodes in 6 months or 4 episodes in 1 year)
no history of significant otitis media (i.e., does not meet criteria for chronic OME or recurrent AOM)

Primary Outcomes

Measure
change in Eustachian tube function
time frame: 5 years

Secondary Outcomes

Measure
change in craniofacial measures
time frame: 5 years

Eligibility Criteria

Male or female participants from 3 years up to 3 years old.

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

Additional Information

Official title Eustachian Tube Growth and Development: Anatomy/Function
Principal investigator William Doyle, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.