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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • real time MRI

    Other intervention

    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

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: child with operated isolated labial cleftExperimental treatment 1 intervention
Group B: child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomyExperimental treatment 1 intervention
Group C: child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomyExperimental treatment 1 intervention
Group D: child with isolated operated velopalatal cleft with normal anatomy and soft VPIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ratio between the diameter of pharynx at rest and during phonation.

Time frame
day 1
2

closure distance between the velar knee and the posterior pharyngeal wall

Time frame
day 1
3

distance between the velar knee and the posterior pharyngeal wall

Time frame
day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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