Articulation and Phonology in Children With Unilateral Cleft Lip and Palate

NCT00829101 | Completed

• 1 other identifier: D-nr: 548/2008
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate; Cleft Lip

Keywords

unilateral cleft lip and palate; primary palatal surgery; articulation; phonology; one stage palatal repair; two stage palatal repair

Outcome Measures

Primary Outcomes (1)

• Percent correct consonants

  3 and 5 years of age

Secondary Outcomes (1)

• Phonological simplification processes

  3 and 5 years of age

Study Arms (3)

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.

Eligibility Criteria

• Age: 3 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• known syndromes and/or additional malformations

Sponsors & Collaborators

• Region Skane: lead
• Karolinska Institutet: collaborator
• Göteborg University: collaborator

Study Sites (1)

Department of Logopedics, Skåne University Hospital Malmö

Malmo, Region Skane, S-205 02, Sweden

Location

Related Publications (5)

• 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.

  PMID: 18335350 BACKGROUND

• 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.

  PMID: 18188776 BACKGROUND

• 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. doi: 10.1597/06-037.1.

  PMID: 17328651 BACKGROUND

• 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.

  PMID: 18215097 BACKGROUND

• 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. doi: 10.1016/s1073-8746(96)80013-2.

  PMID: 9161287 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Henry Svensson, Professor, Head

  Department of Plastic and reconstructive Surgery, Skåne University Hospital, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

SE (1)