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Search / Trial NCT06072495

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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Oct 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Velopharyngeal Insufficiency Real Time Mri Cleft Palate

ClinConnect Summary

This clinical trial is studying a condition called velopharyngeal insufficiency (VPI), which can occur in children who have had surgery for a cleft palate. VPI happens when the soft palate doesn't work properly to separate the nasal and oral cavities, which can lead to speech problems. The researchers are using special types of MRI scans to look at the muscles in the throat of children with different levels of VPI, as well as those with a specific type of cleft lip, to understand how these muscles function and how they might be different.

To participate in this study, children ages 7 to 12 who have had surgery for a cleft lip or palate may be eligible, as long as they are French-speaking and their surgery was done at a specific hospital. Parents can expect their child to undergo safe MRI scans, which are painless and non-invasive, to help researchers learn more about how to improve treatment for VPI. It's important to note that children with certain conditions or those who can't undergo MRI will not be able to participate. This study aims to help create better, personalized rehabilitation and surgical options for children facing these challenges.

Gender

ALL

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.

About Centre Hospitalier Universitaire, Amiens

The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.

Locations

Amiens, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported