Articulation and Phonology in Children With Unilateral Cleft Lip and Palate

Cleft Palate Clinical Trial

— APCLP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829101
• Other study ID #: D-nr: 548/2008
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: July 1, 2014
• Start date: January 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 3 Years

Eligibility

Inclusion Criteria:

• born with unilateral cleft lip and palate

• native Swedish speaking

Exclusion Criteria:

• known syndromes and/or additional malformations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate

Locations

Country	Name	City	State
Sweden	Department of Logopedics, Skåne University Hospital Malmö	Malmo	Region Skane

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Göteborg University, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Farzaneh F, Becker M, Peterson AM, Svensson H. Speech results in adult Swedish patients born with unilateral complete cleft lip and palate. Scand J Plast Reconstr Surg Hand Surg. 2008;42(1):7-13. doi: 10.1080/02844310701694522. — View Citation

Farzaneh F, Lindman R, Becker M, Hansen K, Svensson H. von Langenbeck procedures at 8 months or Wardill at 18 months for primary repair of cleft palate in adult Swedish patients with unilateral complete cleft lip and palate: a study of facial growth. Scand J Plast Reconstr Surg Hand Surg. 2008;42(2):67-76. doi: 10.1080/02844310701850512. — View Citation

Friede H. Maxillary growth controversies after two-stage palatal repair with delayed hard palate closure in unilateral cleft lip and palate patients: perspectives from literature and personal experience. Cleft Palate Craniofac J. 2007 Mar;44(2):129-36. Review. — View Citation

Lohmander A, Persson C. A longitudinal study of speech production in Swedish children with unilateral cleft lip and palate and two-stage palatal repair. Cleft Palate Craniofac J. 2008 Jan;45(1):32-41. doi: 10.1597/06-123.1. — View Citation

Peterson-Falzone SJ. The relationship between timing of cleft palate surgery and speech outcome: what have we learned, and where do we stand in the 1990s? Semin Orthod. 1996 Sep;2(3):185-91. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent correct consonants		3 and 5 years of age	No
Secondary	Phonological simplification processes		3 and 5 years of age	No