Eustachian Tube Growth and Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422929
Recruitment Status : Active, not recruiting
First Posted : January 17, 2007
Last Update Posted : November 14, 2017
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Margaretha L. Casselbrant, 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.

Condition or disease
Otitis Media

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
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eustachian Tube Growth and Development: Anatomy/Function
Study Start Date : August 2006
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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)

Primary Outcome Measures :
  1. change in Eustachian tube function [ Time Frame: 5 years ]
    Eustachian tube function is tested yearly from age 3 years through age 7 years

Secondary Outcome Measures :
  1. change in craniofacial measures [ Time Frame: 5 years ]
    cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years

Other Outcome Measures:
  1. change in cephalometric variables [ Time Frame: 5 years ]
    measurements obtained on cephalometric x-rays

  2. change in later Eustachian tube function [ Time Frame: 11 years ]
    Eustachian tube function tested yearly through 13 years of age

Biospecimen Retention:   Samples With DNA
cells obtained from buccal brushing

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric otolaryngology clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422929

United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study Director: Margaretha Casselbrant, MD, PhD University of Pittsburgh

Publications of Results:
Responsible Party: Margaretha L. Casselbrant, Professor, Otolaryngology, University of Pittsburgh Identifier: NCT00422929     History of Changes
Other Study ID Numbers: #0605009
5P50DC007667-06 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Margaretha L. Casselbrant, University of Pittsburgh:
otitis media
acute otitis
middle ear
Eustachian tube
recurrent acute otitis media
chronic otitis media with effusion
no significant history of otitis media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases