Eustachian Tube Growth and Development
2 other identifiers
observational
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2018
CompletedFebruary 22, 2019
February 1, 2019
10.5 years
January 12, 2007
February 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in Eustachian tube function
Eustachian tube function is tested yearly from age 3 years through age 7 years
5 years
Secondary Outcomes (1)
change in craniofacial measures
5 years
Other Outcomes (2)
change in cephalometric variables
5 years
change in later Eustachian tube function
11 years
Study Arms (3)
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)
Eligibility Criteria
Pediatric otolaryngology clinic
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ENT Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Related Publications (7)
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. 2011 Nov;131(11):1150-4. doi: 10.3109/00016489.2011.603137. Epub 2011 Aug 17.
PMID: 21846295RESULTCasselbrant 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(3):334-7. doi: 10.1016/j.ijporl.2012.11.002. Epub 2012 Dec 30.
PMID: 23280277RESULTCasselbrant 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.
PMID: 24550093RESULTSwarts 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):579-87. doi: 10.3109/00016489.2014.882017.
PMID: 24828350RESULTMandel 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. Epub 2015 Dec 1.
PMID: 26626132RESULTCasselbrant 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.
PMID: 27240512RESULTGremba 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.
PMID: 27063764RESULT
Biospecimen
cells obtained from buccal brushing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Margaretha Casselbrant, MD, PhD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Otolaryngology
Study Record Dates
First Submitted
January 12, 2007
First Posted
January 17, 2007
Study Start
August 1, 2006
Primary Completion
January 16, 2017
Study Completion
August 24, 2018
Last Updated
February 22, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share