Cleft PalateNCT00423072
Middle Ear Pressure Disregulation in Cleft Palate Patients
An observational study of Cleft Palate, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Cleft Palate
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to 22 May 2017
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with cleft palate <2 years of age
Who may be able to join
- birth-24 months
- unrepaired or recently repaired cleft palate
Who cannot join
- cleft palate associated with syndrome
- known immune deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Research Center Childrens' Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates
The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.
Read the detailed description
Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.
- Conditions
- Cleft Palate
- Keywords
- cleft palate, palatoplasty, otitis, middle ear, Eustachian tube
- Medical subject headings
- Cleft Palate, Otitis
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 |
|---|---|---|
| 1 | children with cleft palate birth-24 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
otitis media
status of middle ear at 5 years of age
Measured: 5 years
Secondary outcomes (2)
anatomic variables
MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.
Measured: 3 and 5 years
Eustachian tube function testing
either Forced Response testing or pressure chamber testing
Measured: pre- and post palatoplasty, yearly to age 18 yrs
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 completion27 Mar 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies 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
- 82 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, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423072
- Sponsor's protocol ID
- 0607009
- Other IDs
- 1P50DC007667
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2007
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Pre- and post-palatoplasty Eustachian tube function in infants with cleft palate. Int J Pediatr Otorhinolaryngol. 2012 Mar;76(3):388-91. doi: 10.1016/j.ijporl.2011.12.017. Epub 2012 Jan 9.
PubMed 22230559Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Postpalatoplasty Eustachian tube function in young children with cleft palate. Cleft Palate Craniofac J. 2012 Jul;49(4):504-7. doi: 10.1597/11-065. Epub 2011 Jul 8.
PubMed 21740160Alper CM, Losee JE, Seroky JT, Mandel EM, Richert BC, Doyle WJ. Resolution of Otitis Media With Effusion in Children With Cleft Palate Followed Through Five Years of Age. Cleft Palate Craniofac J. 2016 Sep;53(5):607-13. doi: 10.1597/15-130.
PubMed 27533493
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates
- ClinicalTrials.gov ID
- NCT00423072
- Acronym / sponsor ID
- 0607009
- Conditions
- Cleft Palate
- Keywords
- cleft palate, palatoplasty, otitis, middle ear, Eustachian tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2006
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 22 May 2017 (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.
The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.
Detailed description
Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –children with cleft palate birth-24 months of age |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cleft palate <2 years of age
Key inclusion criteria (2 listed)
- birth-24 months
- unrepaired or recently repaired cleft palate
Key exclusion criteria (2 listed)
- cleft palate associated with syndrome
- known immune deficiency
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
otitis media
Time frame: 5 years
status of middle ear at 5 years of age
2 secondary outcomes
anatomic variables
Time frame: 3 and 5 years
Eustachian tube function testing
Time frame: pre- and post palatoplasty, yearly to age 18 yrs
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 18 Feb 2019.
- Results publication: PubMed 22230559Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Pre- and post-palatoplasty Eustachian tube function in infants with cleft palate. Int J Pediatr Otorhinolaryngol. 2012 Mar;76(3):388-91. doi: 10.1016/j.ijporl.2011.12.017. Epub 2012 Jan 9.
- Results publication: PubMed 21740160Alper CM, Losee JE, Mandel EM, Seroky JT, Swarts JD, Doyle WJ. Postpalatoplasty Eustachian tube function in young children with cleft palate. Cleft Palate Craniofac J. 2012 Jul;49(4):504-7. doi: 10.1597/11-065. Epub 2011 Jul 8.
- Results publication: PubMed 27533493Alper CM, Losee JE, Seroky JT, Mandel EM, Richert BC, Doyle WJ. Resolution of Otitis Media With Effusion in Children With Cleft Palate Followed Through Five Years of Age. Cleft Palate Craniofac J. 2016 Sep;53(5):607-13. doi: 10.1597/15-130.
- 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.
Cuneyt M Alper, MD principal investigator
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 Cleft Palate, 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 2 inclusion and 2 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 18 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?
otitis media (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 NCT00423072, which also lists 3 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 18 Feb 2019.