Timing of Primary Surgery for Cleft Palate

Timing of Primary Surgery for Cleft Palate

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.

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)

Inclusion Criteria:

• Infants with isolated cleft palate
• Medically fit for operation at 6 months, corrected for gestational age
• Written informed proxy consent
• One parent/carer a native language speaker in the country of residence

Exclusion Criteria:

• Consent not obtained
• b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay
• Congenital sensorineural hearing loss or middle ear anomalies;
• Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate;
• Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988).
• Where the language spoken at home is not the majority language in the country of residence.