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Articulation and Phonology in Children With Unilateral Cleft Lip and Palate (APCLP)

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Göteborg University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00829101
First received: January 23, 2009
Last updated: July 1, 2014
Last verified: July 2014
  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
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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Percent correct consonants [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phonological simplification processes [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children from the south or western region of Sweden born with unilateral cleft lip and palate.

Criteria

Inclusion Criteria:

  • born with unilateral cleft lip and palate
  • native Swedish speaking

Exclusion Criteria:

  • known syndromes and/or additional malformations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829101

Locations
Sweden
Department of Logopedics, Skåne University Hospital Malmö
Malmo, Region Skane, Sweden, S-205 02
Sponsors and Collaborators
Region Skane
Karolinska Institutet
Göteborg University
Investigators
Study Director: Henry Svensson, Professor, Head Department of Plastic and reconstructive Surgery, Skåne University Hospital, Sweden
  More Information

Publications:
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: July 1, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
unilateral cleft lip and palate
primary palatal surgery
articulation
phonology
one stage palatal repair
two stage palatal repair

Additional relevant MeSH terms:
Craniofacial Abnormalities
Cleft Lip
Cleft Palate
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Lip Diseases
Maxillofacial Abnormalities
Mouth Abnormalities
Mouth Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic Diseases
Stomatognathic System Abnormalities

ClinicalTrials.gov processed this record on November 20, 2014