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

Cleft Palate Clinical Trial

— FENTIRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072495
• Other study ID #: PI2021_843_0208
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Cica-Carole GBAGUIDI, MD
• Phone: 0322089050
• Email: Gbaguidi.Cica-Carole[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refusal of the parents and/or the patient
• With a contraindication to MRI
• Whose follow-up was initiated in another center and/or whose surgery was performed in another center
• Whose surgical schedule has not been followed
• Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
• Patients treated with fixed, non-removable orthodontic treatment.

Related Conditions & MeSH terms

• Cleft Palate
• Velopharyngeal Insufficiency

Intervention

Other:
• real time MRI
ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ratio between the diameter of pharynx at rest and during phonation.		day 1
Primary	closure distance between the velar knee and the posterior pharyngeal wall		day 1
Primary	distance between the velar knee and the posterior pharyngeal wall		day 1