Middle Ear Pressure Disregulation in Cleft Palate Patients
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates|
- otitis media [ Time Frame: 5 years ] [ Designated as safety issue: No ]status of middle ear at 5 years of age
- anatomic variables [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.
- Eustachian tube function testing [ Time Frame: pre- and post palatoplasty, yearly to age 6 yrs ] [ Designated as safety issue: No ]either Forced Response testing or pressure chamber testing
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
children with cleft palate birth-24 months of age
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423072
|United States, Pennsylvania|
|ENT Research Center Childrens' Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||William Doyle, PhD||Children's Hospital of Pittsburgh|
|Study Director:||Cuneyt Alper, MD||Children's Hospital of Pittsburgh|