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NCT Number: NCT06072495

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

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).

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Key information

Conditions

Velopharyngeal Insufficiency Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Real Time MRI Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

Location status: Recruiting

Location contact

Cica-Carole Gbaguidi, MD

CONTACT

[email protected]

0322089050

Jean-Marc CONSTANS, Pr

SUB_INVESTIGATOR

Sylvie TESTELIN, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

real time MRI

Other

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cica-Carole GBAGUIDI, MD

CONTACT

[email protected]

0322089050

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: FENTIRM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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