Eustachian Tube Growth and Development

Otitis Media Clinical Trial

Official title:

Eustachian Tube Growth and Development: Anatomy/Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422929
• Other study ID #: #0605009
• Secondary ID: 5P50DC007667-06
• Status: Completed
• Start date: August 2006
• Est. completion date: August 24, 2018

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 24, 2018
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Locations

Country	Name	City	State
United States	ENT Research Center, Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Casselbrant ML, Mandel EM, Doyle WJ. Information on co-morbidities collected by history is useful for assigning Otitis Media risk to children. Int J Pediatr Otorhinolaryngol. 2016 Jun;85:136-40. doi: 10.1016/j.ijporl.2016.03.040. Epub 2016 Apr 11. — View Citation

Casselbrant ML, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. A pilot study of the ability of the forced response test to discriminate between 3-year-old children with chronic otitis media with effusion or with recurrent acute otitis media. Acta Otolaryngol. — View Citation

Casselbrant ML, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. The forced-response test does not discriminate ears with different otitis media expressions. Laryngoscope. 2014 Nov;124(11):2619-23. doi: 10.1002/lary.24647. Epub 2014 Aug 11. — View Citation

Casselbrant ML, Swarts JD, Mandel EM, Doyle WJ. The Cephalic Index is not different among groups of children aged 36-48 months with chronic otitis media with effusion, recurrent acute otitis media and controls. Int J Pediatr Otorhinolaryngol. 2013 Mar;77( — View Citation

Gremba AP, Weinberg SM, Swarts JD, Casselbrant ML. Craniofacial shape in children with and without a positive otitis media history. Int J Pediatr Otorhinolaryngol. 2016 May;84:110-5. doi: 10.1016/j.ijporl.2016.02.029. Epub 2016 Mar 5. — View Citation

Mandel EM, Casselbrant ML, Richert BC, Teixeira MS, Swarts JD, Doyle WJ. Eustachian Tube Function in 6-Year-Old Children with and without a History of Middle Ear Disease. Otolaryngol Head Neck Surg. 2016 Mar;154(3):502-7. doi: 10.1177/0194599815620149. Ep — View Citation

Swarts JD, Casselbrant ML, Teixeira MS, Mandel EM, Richert BC, Banks JM, El-Wagaa J, Doyle WJ. Eustachian tube function in young children without a history of otitis media evaluated using a pressure chamber protocol. Acta Otolaryngol. 2014 Jun;134(6):579- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in cephalometric variables	measurements obtained on cephalometric x-rays	5 years
Other	change in later Eustachian tube function	Eustachian tube function tested yearly through 13 years of age	11 years
Primary	change in Eustachian tube function	Eustachian tube function is tested yearly from age 3 years through age 7 years	5 years
Secondary	change in craniofacial measures	cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years	5 years