NCT00993551

Timing of Primary Surgery for Cleft Palate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Kevin Munro · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: * Surgery at age 6 months, OR * Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

Detailed description

Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed: Age 12 months * Speech development (canonical babbling) * Audiological assessments * Growth Age 3 years * Speech development * Audiological assessments Age 5 Years * Speech development * Audiological assessments * Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)

Conditions

• Cleft Palate

Interventions

Type	Name	Description
PROCEDURE	primary surgery for cleft palate	Surgery completed using the Sommerlad technique

Timeline

• Start date: 2010-07-01
• Primary completion: 2020-08-01
• Completion: 2021-03-26
• First posted: 2009-10-12
• Last updated: 2021-08-13

Locations

23 sites across 5 countries: Brazil, Denmark, Norway, Sweden, United Kingdom