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

Not Applicable

Recruiting

• Conditions: Cleft Palate; Velopharyngeal Insufficiency; Real Time MRI
• Interventions: Other: real time MRI

• Registration Number: NCT06072495
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
child with operated isolated labial cleft	real time MRI	-
child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy	real time MRI	-
child with isolated operated velopalatal cleft with normal anatomy and soft VPI	real time MRI	-
child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy	real time MRI	-

Primary Outcome Measures

Name	Time	Method
distance between the velar knee and the posterior pharyngeal wall	day 1
closure distance between the velar knee and the posterior pharyngeal wall	day 1
ratio between the diameter of pharynx at rest and during phonation.	day 1

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France