This trial is active, not recruiting.

Condition cleft palate
Sponsor University of Pittsburgh
Collaborator National Institute on Deafness and Other Communication Disorders (NIDCD)
Start date August 2006
End date June 2020
Trial size 220 participants
Trial identifier NCT00423072, 0607009, 1P50DC007667


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
children with cleft palate birth-24 months of age

Primary Outcomes

otitis media
time frame: 5 years

Secondary Outcomes

anatomic variables
time frame: 3 and 5 years
Eustachian tube function testing
time frame: pre- and post palatoplasty, yearly to age 18 yrs

Eligibility Criteria

Male or female participants up to 24 months old.

Inclusion Criteria: - birth-24 months - unrepaired or recently repaired cleft palate Exclusion Criteria: - cleft palate associated with syndrome - known immune deficiency

Additional Information

Official title Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates
Principal investigator Cuneyt M Alper, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.