Articulation and Phonology in Children With Unilateral Cleft Lip and Palate (APCLP)
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| First Received Date ICMJE | January 23, 2009 | ||||
| Last Updated Date | August 28, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percent correct consonants [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00829101 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Phonological simplification processes [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Articulation and Phonology in Children With Unilateral Cleft Lip and Palate | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children from the south or western region of Sweden born with unilateral cleft lip and palate. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | May 2014 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 3 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00829101 | ||||
| Other Study ID Numbers ICMJE | D-nr: 548/2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Region Skane | ||||
| Study Sponsor ICMJE | Region Skane | ||||
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| Investigators ICMJE |
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| Information Provided By | Region Skane | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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