Cleft Palate – Furlow Palatoplasty Study

Protocol Description

This study will look at whether a standard method for repairing a cleft palate can be improved by stitching down a muscle related to middle ear function that is routinely cut during surgery. Almost all infants and young children who were born with a cleft palate (with or without a cleft lip) have middle ear disease caused by an inability to open the Eustachian tube that connects the nose with the middle ear. This condition can last into late childhood and early adolescence. Through this study, surgeons will compare the results of a standard surgical procedure to repair the cleft palate, called Furlow palatoplasty, with a modified Furlow procedure that includes tensor tenopexy (stitching the muscle).

Eligibility Criteria

Subject to certain exclusion criteria, children of both genders, up to age 15 months, will be entered into the study prior to cleft palate repair.
Boys: Up to 15 months of age
Girls: Up to 15 months of age

Requirements

Half the children in the study will have surgery with the usual method, and half will have the modified procedure. The occurrence of ear disease in these two groups through the age of 7 years will be compared. These examinations will include otoscopy and tympanometry. Beginning at 3 years of age, every other visit will include Eustachian tube function testing.
Visits: 4 per year (Can be at same time as appointments in Cleft-Craniofacial Center.)
Duration: 7 years

Status: Closed to Enrollment

Source(s) of Support

National Institute on Deafness and Other Communication Disorders

Additional Information

Study description at the National Institutes of Health

Primary Investigator

Cuneyt Alper, MD
Joseph Losee, MD

Contact Information

For information or to enroll, please contact:
Jim Seroky, MA
412-692-5463