Middle Ear Pressure Disregulation in Cleft Palate Patients

Completed

Conditions studied: Cleft Palate

In brief

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.

Key facts

Study ID

NCT00423072

Run by

University of Pittsburgh

People needed

82

Starts

2006-08-01

Expected to finish

2017-05-22

Last updated by the study team

2019-02-18

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• cleft palate associated with syndrome
• known immune deficiency

Where it is running

• ENT Research Center Childrens' Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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