Timing of Primary Surgery for Cleft Palate

2014-07-23 21:12:29 | BioPortfolio


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 specified technique, at age 6 months, when compared to surgery using the same technique age 12 months, improves speech development. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes(age 5) 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 (cannonical babbling)

- Audiological assessments

- OM8-30 questionnaires (completed by the parent)

Age 3 years

- Speech development

- Audiological assessments

- OM8-30 questionnaire

Age 5 Years

- Speech development

- Audiological assessments

- OM8-30 questionnaire

- Dentofacial development (dental impressions and photographs)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Cleft Palate


primary surgery for cleft palate


Not yet recruiting


University of Manchester

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:12:29-0400

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