Eustachian Tube Growth and Development

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaretha L. Casselbrant, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00422929
First received: January 12, 2007
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This study is to measure over time (from 3 years until 7 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
Otitis Media

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eustachian Tube Growth and Development: Anatomy/Function

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • change in Eustachian tube function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Eustachian tube function is tested yearly from age 3 years through age 7 years


Secondary Outcome Measures:
  • change in craniofacial measures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years


Other Outcome Measures:
  • change in cephalometric variables [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    measurements obtained on cephalometric x-rays


Biospecimen Retention:   Samples With DNA

cells obtained from buccal brushing


Estimated Enrollment: 150
Study Start Date: August 2006
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   3 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric otolaryngology clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422929

Locations
United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: William Doyle, PhD Children's Hospital of Pittsburgh
Study Director: Margaretha Casselbrant, MD, PhD Children's Hospital of Pittsburgh
  More Information

Publications:
Responsible Party: Margaretha L. Casselbrant, Director of Research, ENT Department, CHP, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00422929     History of Changes
Other Study ID Numbers: #0605009, 5P50DC007667-06
Study First Received: January 12, 2007
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
otitis media
ear
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
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014