Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423072
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2007-01-12
Brief Title:
Middle Ear Pressure Disregulation in Cleft Palate Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Middle Ear Pressure Disregulation in Cleft Palate Patients Form-Function Correlates
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 presenceabsence 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50DC007667 | NIH | None | httpsreporternihgovquickSearch1P50DC007667 |