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

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).

Study Overview

• Status: Recruiting
• Conditions: Cleft Palate; Velopharyngeal Insufficiency; Real Time MRI
• Intervention / Treatment: Other: real time MRI

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cica-Carole Gbaguidi, MD; Phone Number: 0322089050; Email: Gbaguidi.Cica-Carole@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Sub-Investigator: Sylvie Testelin, Pr
    • Contact: Cica-Carole Gbaguidi, MD; Phone Number: 0322089050; Email: Gbaguidi.Cica-Carole@chu-amiens.fr
    • Sub-Investigator: Jean-Marc CONSTANS, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: child with operated isolated labial cleft	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
Experimental: child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy	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
Experimental: child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy	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
Experimental: child with isolated operated velopalatal cleft with normal anatomy and soft VPI	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cleft palate; Velopharyngeal Insufficiency; real time MRI
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Velopharyngeal Insufficiency
• Other Study ID Numbers: PI2021_843_0208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No