Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: real time MRI.
- Who it may be relevant to
- Registry conditions: Velopharyngeal Insufficiency, Real Time MRI, Cleft Palate. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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
Primary outcome measures
- ratio between the diameter of pharynx at rest and during phonation. [Time frame: day 1]
- closure distance between the velar knee and the posterior pharyngeal wall [Time frame: day 1]
- distance between the velar knee and the posterior pharyngeal wall [Time frame: day 1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens-Picardie — Amiens
Identifiers
NCT: NCT06072495 · PI2021_843_0208