Informations générales (source: ClinicalTrials.gov)
Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI (FENTIRM)
Interventional
N/A
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
octobre 2023
décembre 2024
29 juin 2024
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Amiens-Picardie - 80054 - Amiens - France | Cica-Carole Gbaguidi, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.