This clinical trial planning grant is to design a multi-center, multi-disciplinary prospectively randomized trial to evaluate the outcomes following two cleft palate repair techniques--Furlow double-Z palatoplasty (Double Z) and intra-velar veloplasty (IVV).
The specific aims of the study are to determine if the primary endpoints of the occurrence of oro-nasal fistulae and the rate of velopharyngeal insufficiently of children undergoing double Z or IVV palatoplasty at 10-12 months of age are the same. It is also believed that cleft type and cleft width may influence these primary endpoints, a series of specific measurements of palatal architecture will be made at the time of palatal repair. Secondary endpoints will be to determine if the occurrence of oro-nasal fistulae or velopharyngeal competence differs as a result of any of these architectural parameters in the two techniques of palatal repair. Patients will be recruited from four major referral sites: Riley Hospital for Children, Children's Medical Center of Akron, Mott Children's Hospital and Children's Mercy Hospital in Kansas City. Total planned enrollment in the trial is 300 cleft patients over three years. Prior to surgery, appropriate screens will be performed to exclude patients with cognitive delay, sensori-neuronal hearing loss, or neuromuscular disorders. All non-syndromic patients with cleft palate, with or without cleft lip, will be offered participation in the trial. Audiology testing will be performed throughout the study to minimize the influence of hearing loss upon the data. A speech-language assessment will be performed at nine months of age, and follow-up speech language assessments will be at six-month intervals until 36 months of age, and on an annual basis thereafter until six years of age, or until secondary surgical management is recommended. In addition, a master tape at the 48-month visit will be sent to five independent speech-language pathologists for evaluation in a blinded fashion. Velopharyngeal assessment will be made using nasometry management and analysis will be performed through a separate data center. There are no randomized controlled trials published that compare these techniques of double Z or IVV, and, furthermore, there have been very few randomized trials published in cleft studies, despite this being the third most common birth defect. In addition, there have been no studies on the palatal architecture parameters and their influence upon oronasal fistulae and velopharyngeal competence that have been published.
