Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06072495
Acronym
FENTIRM
Enrollment
30
Registered
2023-10-10
Start date
2024-11-06
Completion date
2026-06-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate, Real Time MRI, Velopharyngeal Insufficiency

Keywords

Velopharyngeal Insufficiency, real time MRI, Cleft palate

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).

Interventions

OTHERreal 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
ratio between the diameter of pharynx at rest and during phonation.day 1
closure distance between the velar knee and the posterior pharyngeal wallday 1
distance between the velar knee and the posterior pharyngeal wallday 1

Countries

France

Contacts

CONTACTCica-Carole GBAGUIDI, MD
Gbaguidi.Cica-Carole@chu-amiens.fr0322089050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026