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Middle Ear Pressure Disregulation in Cleft Palate Patients
This study is currently recruiting participants.
Verified by Children's Hospital of Pittsburgh, February 2009
First Received: January 12, 2007   Last Updated: February 13, 2009   History of Changes
Sponsor: Children's Hospital of Pittsburgh
Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00423072
  Purpose

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.


Condition
Cleft Palate

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Pittsburgh:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 220
Study Start Date: August 2006
Groups/Cohorts
1
children with cleft palate birth-24 months of age

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). 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
Study Population

Children with cleft palate <2 years of age

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • cleft palate associated with syndrome
  • known immune deficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423072

Contacts
Contact: Kathy Tekely, RN 412-692-5463
Contact: Ellen Mandel, MD 412-692-5463

Locations
United States, Pennsylvania
ENT Research Center Childrens' Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: William Doyle, PhD Children's Hospital of Pittsburgh
Study Director: Cuneyt Alper, MD Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh School of Medicine ( William J. Doyle, PhD )
Study ID Numbers: 0607009, NIH 1P50DC007667
Study First Received: January 12, 2007
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00423072     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
cleft palate
palatoplasty
otitis
middle ear
Eustachian tube

Additional relevant MeSH terms:
Mouth Diseases
Cleft Palate
Musculoskeletal Diseases
Mouth Abnormalities
Craniofacial Abnormalities
Jaw Diseases
Stomatognathic System Abnormalities
Jaw Abnormalities
Stomatognathic Diseases
Maxillofacial Abnormalities
Congenital Abnormalities
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on November 27, 2009