Middle Ear Pressure Disregulation in Cleft Palate Patients

Completed

• Conditions: Cleft Palate

• Registration Number: NCT00423072
• Lead Sponsor: University of Pittsburgh

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-17
• Primary Completion: 2017-03-27
• Study Completion: 2017-05-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• birth-24 months
• unrepaired or recently repaired cleft palate

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Exclusion Criteria

• cleft palate associated with syndrome
• known immune deficiency

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
otitis media	5 years	status of middle ear at 5 years of age

Secondary Outcome Measures

Name	Time	Method
anatomic variables	3 and 5 years	MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.
Eustachian tube function testing	pre- and post palatoplasty, yearly to age 18 yrs	either Forced Response testing or pressure chamber testing

Trial Locations

Locations (1)

ENT Research Center Childrens' Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States