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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Karolinska Institutet
Göteborg University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00829101
First received: January 23, 2009
Last updated: August 28, 2012
Last verified: August 2012

January 23, 2009
August 28, 2012
January 2009
May 2014   (final data collection date for primary outcome measure)
Percent correct consonants [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829101 on ClinicalTrials.gov Archive Site
Phonological simplification processes [ Time Frame: 3 and 5 years of age ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Articulation and Phonology in Children With Unilateral Cleft Lip and Palate
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Cleft Palate
  • Cleft Lip
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • known syndromes and/or additional malformations
Both
3 Years to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00829101
D-nr: 548/2008
No
Region Skane
Region Skane
  • Karolinska Institutet
  • Göteborg University
Study Director: Henry Svensson, Professor, Head Department of Plastic and reconstructive Surgery, Skåne University Hospital, Sweden
Region Skane
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP