An observational study in Cleft Palate and Cleft Lip, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 3 Years to 3 Years. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Region Skane · Observational
The purpose of the study is to assess if there are any differences in the articulatory and phonological competence in pre-school children with unilateral cleft lip and palate (UCLP) who are treated with different surgical methods of palatal repair.
A cleft palate may influence important functions such as eating, function of the ear/hearing, speech, occlusion, and in addition social skills and acceptability related to appearance. Surgical treatment is aiming to minimize the impact of the cleft on these functions. Nevertheless there is often a need of orthodontic treatment, and if the palate is involved, speech therapy and speech improving secondary surgery. The incidence of otitis media with effusion, and related hearing problems, is high among the children. The outcome is affected by type of cleft as well as surgical method, although not yet fully clarified. Some consider the growth of the mid-face to be better if primary surgery of the hard palate is delayed, while speech development is considered to benefit from primary palate surgery performed as early as possible. Yet we don´t know which surgical method is the best. In most parts of the world and at three of six treatment centers in Sweden the palate is closed in one stage between 12 and 18 months of age. At the three other Swedish centers the cleft in the soft palate is closed at 4-6 months, and the cleft in the hard palate is repaired at 2-3 years of age.
Video-recordings of the children at 3 and 5 years of age will be used for evaluation. The speech material at 3 years of age consists of spontaneous speech and word naming. At 5 years sentence repetition and a re-telling task is added. Blindly transcription of the material after randomization, according to the transcription used for cleft palate speech in Sweden based on the IPA and ExtIPA conventions will be performed. About 30% of the material, randomly selected, will be re-transcribed and about 30% will be transcribed by an additional listener independently, for calculation of reliability. The results will be compared between groups regarding articulatory deviancies and phonological processes, and will be statistically analyzed. Impact of ear problems, hearing and speech therapy will be assessed.
131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.
This study's enrollment of 30 is below the median of 96 across 40 observational studies indexed under Cleft Palate.
Browse Cleft Palate studies →Region Skane is the lead sponsor of 369 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children from the south or western region of Sweden born with unilateral cleft lip and palate.
Exclusion Criteria:
A consecutive group of children born with unilateral cleft lip and palate from the south region of Sweden, in all 10 children, who have had a primary palatal surgery at 12 months of age.
A consecutive group of children born with unilateral cleft lip and palate from the western region of Sweden, in all 10 children, who have had a two-stage palatal surgery, with soft palate closure at 4-6 months and repair of the hard palate at 12 months of age.
A consecutive group of children born with unilateral cleft lip and palate from the western region of Sweden, in all 10 children, who have have had a two-stage palatal surgery, with soft palate closure at 4-6 months and repair of the hard palate at 36 months of age.
Percent correct consonants
Time frame: 3 and 5 years of age
Phonological simplification processes
Time frame: 3 and 5 years of age
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Region Skane