Comparing speech outcomes in children with cleft palate after two surgical techniques
A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow Palatoplasty in Combination With Intravelar Veloplasty According to Sommerlad, or Modified Furlow Palatoplasty Alone
This study is testing whether a combined surgery for children with cleft palates can lead to better speech outcomes compared to a single surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Brugge) |
| Trial ID | NCT03995199 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the speech outcomes of pediatric patients with cleft palates who have undergone two different surgical techniques: the modified Furlow palatoplasty alone and the modified Furlow palatoplasty combined with Sommerlad's intravelar veloplasty. The study aims to determine if the combined surgical approach significantly reduces the incidence of abnormal speech in children aged five to seven years, as assessed by a standardized speech evaluation scale. Patients will be followed annually by a speech language pathologist, and their parents will complete quality of life questionnaires regarding their child's speech development.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking children diagnosed with a cleft of the hard and/or soft palate who are undergoing the specified surgical techniques.
Not a fit: Patients who have received corrective surgery for velopharyngeal dysfunction or are bi- or multilingual may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved speech outcomes for children with cleft palates, enhancing their quality of life.
How similar studies have performed: While similar studies have explored surgical techniques for cleft palate, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients should have a clinically diagnosed cleft of the hard and/or soft palatum, with or without involvement of the lip or nose (Veau classification I to IV (see Appendix 1). * Patients should have undergone a modified Furlow palatoplasty or modified Furlow according to Sommerlad in the AZ Sint-Jan Brugge-Oostende av * Patients should receive their postoperative care and speech therapy by the cleft team of the general hospital Sint-Jan Bruges * Patients should be in the fifth life year at time of speech evaluation * Patients should be Dutch-speaking as a maternal language Exclusion Criteria: * Patients not meeting the abovementioned inclusion criteria * Patients that received a corrective surgical procedure for velopharyngeal dysfunction after the modified Furlow technique alone, or in combination with the intravelar veloplasty by Sommerlad * Patients that are bi- or multilingual * Patients with clinically diagnosed mild hearing difficulties (i.e. ASHA classification: hearing loss \>25dB)30 * Patients with a clinically diagnosed stutter * Patients with clinically diagnosed cognitive and/or motoric disabilities * Patients that received intensive speech therapy prior to their fifth life year can be included, but will be analyzed separately(subgroup analysis) * Note: The number of patients with a uni- or bilateral cleft involving the lip or nose should be comparable between both groups, since this can interfere with speech and could bias comparison of speech outcome between different cleft subgroups.
Where this trial is running
Brugge
- Division of oral and maxillofacial surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV — Brugge, Belgium (Recruiting)
Study contacts
- Study coordinator: Araceli Diez-Fraile
- Email: araceli.diez-fraile@azsintjan.be
- Phone: +32 5045 9660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.