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.