Timing of Primary Surgery for Cleft Palate — TOPS  

Cleft Palate Clinical Trial

Official title: Timing of Primary Surgery for Cleft Palate

Status Completed

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Cleft Palate

• NCT number: NCT00993551
• Study type: Interventional
• Source: University of Manchester
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Completion date: March 26, 2021