Eustachian Tube Growth and Development

February 20, 2019 updated by: Margaretha L. Casselbrant, University of Pittsburgh

Eustachian Tube Growth and Development: Anatomy/Function

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • ENT Research Center, Children's Hospital of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric otolaryngology clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)
recurrent AOM
recurrent acute otitis media (3 episodes in 6 months or 4 episodes in 1 year)
no OM
no history of significant otitis media (i.e., does not meet criteria for chronic OME or recurrent AOM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Eustachian tube function
Time Frame: 5 years
Eustachian tube function is tested yearly from age 3 years through age 7 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in craniofacial measures
Time Frame: 5 years
cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in cephalometric variables
Time Frame: 5 years
measurements obtained on cephalometric x-rays
5 years
change in later Eustachian tube function
Time Frame: 11 years
Eustachian tube function tested yearly through 13 years of age
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Study Director: Margaretha Casselbrant, MD, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

January 16, 2017

Study Completion (Actual)

August 24, 2018

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0605009
  • 5P50DC007667-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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