Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• Children aged 7 to 12 years with Isolated cleft lip

• isolated velopalatal cleft

• Without a diagnosis of syndromic cleft or Pierre Robin sequence

• French speaking, and French is the native language

• Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital

• Whose follow-up is done at the Amiens University Hospital

Locations
Other Locations
France
CHU Amiens-Picardie
RECRUITING
Amiens
Contact Information
Primary
Cica-Carole GBAGUIDI, MD
Gbaguidi.Cica-Carole@chu-amiens.fr
0322089050
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 30
Treatments
Experimental: child with operated isolated labial cleft
Experimental: child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy
Experimental: child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy
Experimental: child with isolated operated velopalatal cleft with normal anatomy and soft VPI
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov