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

Primary Purpose

Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
real time MRI
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Velopharyngeal Insufficiency focused on measuring Velopharyngeal Insufficiency, real time MRI, Cleft palate

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Amiens-PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

child with operated isolated labial cleft

child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy

child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy

child with isolated operated velopalatal cleft with normal anatomy and soft VPI

Arm Description

Outcomes

Primary Outcome Measures

ratio between the diameter of pharynx at rest and during phonation.
closure distance between the velar knee and the posterior pharyngeal wall
distance between the velar knee and the posterior pharyngeal wall

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT06072495
Brief Title
Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate
Keywords
Velopharyngeal Insufficiency, real time MRI, Cleft palate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
child with operated isolated labial cleft
Arm Type
Experimental
Arm Title
child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy
Arm Type
Experimental
Arm Title
child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy
Arm Type
Experimental
Arm Title
child with isolated operated velopalatal cleft with normal anatomy and soft VPI
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
real time MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
ratio between the diameter of pharynx at rest and during phonation.
Time Frame
day 1
Title
closure distance between the velar knee and the posterior pharyngeal wall
Time Frame
day 1
Title
distance between the velar knee and the posterior pharyngeal wall
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cica-Carole GBAGUIDI, MD
Phone
0322089050
Email
Gbaguidi.Cica-Carole@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cica-Carole Gbaguidi, MD
Phone
0322089050
Email
Gbaguidi.Cica-Carole@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Sylvie TESTELIN, Pr
First Name & Middle Initial & Last Name & Degree
Jean-Marc CONSTANS, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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