Eustachian Tube Growth and Development
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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 |
cells obtained from buccal brushing
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2006 |
| Groups/Cohorts |
|---|
|
chronic 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 (F) 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 |
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
Contacts and Locations| Contact: Kathy Tekely, RN | 412-692-5463 | |
| Contact: Ellen Mandel, MD | 412-692-5463 |
| United States, Pennsylvania | |
| ENT Research Center, Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | William Doyle, PhD | Children's Hospital of Pittsburgh |
| Study Director: | Margaretha Casselbrant, MD, PhD | Children's Hospital of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Margaretha Casselbrant, Director of Research, ENT Department, CHP, Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00422929 History of Changes |
| Other Study ID Numbers: | #0605009, 5P50DC007667-06 |
| Study First Received: | January 12, 2007 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital 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 May 16, 2013