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Middle Ear Pressure Disregulation in Cleft Palate Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00423072
First received: January 12, 2007
Last updated: February 18, 2014
Last verified: February 2014
  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: Observational Model: Cohort
Time Perspective: 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 University of Pittsburgh:

Primary Outcome Measures:
  • otitis media [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    status of middle ear at 5 years of age


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 220
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)
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). 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423072

Locations
United States, Pennsylvania
ENT Research Center Childrens' Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University 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

Publications:
Responsible Party: William J. Doyle, Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00423072     History of Changes
Other Study ID Numbers: 0607009, NIH 1P50DC007667
Study First Received: January 12, 2007
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cleft palate
palatoplasty
otitis
middle ear
Eustachian tube

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

ClinicalTrials.gov processed this record on November 24, 2014