Otitis MediaNCT00422929
Eustachian Tube Growth and Development
An observational study of Otitis Media, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to 24 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric otolaryngology clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Eustachian Tube Growth and Development: Anatomy/Function
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.
Read the 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.
- Conditions
- Otitis Media
- Keywords
- otitis media, ear, acute otitis, middle ear, Eustachian tube, recurrent acute otitis media, chronic otitis media with effusion, no significant history of otitis media
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Eustachian tube function
Eustachian tube function is tested yearly from age 3 years through age 7 years
Measured: 5 years
Secondary outcomes (1)
change in craniofacial measures
cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startAug 2006
- Primary completion16 Jan 2017
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Margaretha L. Casselbrant, University of Pittsburgh
- Investigators
- Margaretha Casselbrant, MD, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422929
- Sponsor's protocol ID
- #0605009
- Other IDs
- 5P50DC007667-06
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2007
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21846295Casselbrant 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.
PubMed 23280277Casselbrant 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.
PubMed 24550093Swarts 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.
PubMed 24828350Mandel 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.
PubMed 26626132Casselbrant 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.
PubMed 27240512Gremba 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.
PubMed 27063764
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eustachian Tube Growth and Development: Anatomy/Function
- ClinicalTrials.gov ID
- NCT00422929
- Acronym / sponsor ID
- #0605009
- Conditions
- Otitis Media
- Keywords
- otitis media, ear, acute otitis, middle ear, Eustachian tube, recurrent acute otitis media, chronic otitis media with effusion, no significant history of otitis media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2006 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 17 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric otolaryngology clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in Eustachian tube function
Time frame: 5 years
Eustachian tube function is tested yearly from age 3 years through age 7 years
1 secondary outcome
change in craniofacial measures
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Results publication: PubMed 21846295Casselbrant 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.
- Results publication: PubMed 23280277Casselbrant 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.
- Results publication: PubMed 24550093Casselbrant 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.
- Results publication: PubMed 24828350Swarts 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.
- Results publication: PubMed 26626132Mandel 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.
- Results publication: PubMed 27240512Casselbrant 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.
- Results publication: PubMed 27063764Gremba 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaretha Casselbrant, MD, PhD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Eustachian tube function (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00422929, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.