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| Sponsor: | Region Skane |
|---|---|
| Collaborators: |
Karolinska Institutet Göteborg University |
| Information provided by (Responsible Party): | Region Skane |
| ClinicalTrials.gov Identifier: | NCT00829101 |
Purpose
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.
| Condition |
|---|
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Cleft Palate Cleft Lip |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Articulatory and Phonological Competence at 3 and 5 Years of Age in Children With Unilateral Cleft Lip and Palate Who Have Undergone Different Methods of Primary Palatal Surgery |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1 One-stage repair
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.
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2 Two-stage repair, early closure
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.
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3 Two-stage repair, delayed closure
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.
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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.
Eligibility| Ages Eligible for Study: | 3 Years to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children from the south or western region of Sweden born with unilateral cleft lip and palate.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kristina E A Klintö, Phd student | +4646331024 | kristina.klinto@skane.se |
| Sweden | |
| Department of Logopedics, Skåne University Hospital Malmö | Recruiting |
| Malmo, Region Skane, Sweden, S-205 02 | |
| Contact: Kristina E A Klintö, Phd-student +4640331024 kristina.klinto@skane.se | |
| Study Director: | Henry Svensson, Professor, Head | Department of Plastic and reconstructive Surgery, Skåne University Hospital, Sweden |
More Information
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT00829101 History of Changes |
| Other Study ID Numbers: | D-nr: 548/2008 |
| Study First Received: | January 23, 2009 |
| Last Updated: | August 22, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
|
unilateral cleft lip and palate primary palatal surgery articulation |
phonology one stage palatal repair two stage palatal repair |
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Cleft Lip Cleft Palate Lip Diseases Mouth Diseases Stomatognathic Diseases Mouth Abnormalities Stomatognathic System Abnormalities |
Congenital Abnormalities Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities |
