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| Sponsors and Collaborators: |
Children's Hospital of Pittsburgh National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by: | Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00423072 |
Purpose
We 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. We 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. We 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.
| Condition |
|
Cleft Palate |
| Genetics Home Reference related topics: | Baller-Gerold syndrome Crouzon syndrome |
| MedlinePlus related topics: | Cleft Lip and Palate Ear Disorders |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates |
| Estimated Enrollment: | 220 |
| Study Start Date: | August 2006 |
| Groups/Cohorts |
|
1
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). We 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, we 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.
Eligibility
| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children with cleft palate <2 years of age
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathy Tekely, RN | 412-692-5463 | |
| Contact: Ellen Mandel, MD | 412-692-5463 |
| United States, Pennsylvania | |||||
| ENT Research Center Childrens' Hospital of Pittsburgh | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Children's Hospital of Pittsburgh |
| National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Principal Investigator: | William Doyle, PhD | Children's Hospital of Pittsburgh |
| Study Director: | Cuneyt Alper, MD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh School of Medicine ( William J. Doyle, PhD ) |
| Study ID Numbers: | 0607009, NIH 1P50DC007667 |
| First Received: | January 12, 2007 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00423072 |
| Health Authority: | United States: Institutional Review Board |
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