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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Real Time MRI; Cleft Palate; Velopharyngeal Insufficiency

Treatments: Other: real time MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06072495

PI2021_843_0208

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups

child with operated isolated labial cleft

Experimental group

Treatment:

Other: real time MRI

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

Experimental group

Treatment:

Other: real time MRI

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

Experimental group

Treatment:

Other: real time MRI

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

Experimental group

Treatment:

Other: real time MRI