Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT00993551
Brief 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)
Study:
NCT00993551
Study Brief:
Protocol Section:
NCT00993551