NCT03194178

Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Imagine Institute · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The study team has made the hypothesis that the intensity of the phonatory disorders (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have negative effects on the quality of life of adolescents with Pierre Robin sequence. The investigators also want to assess the impact of 2 different surgical protocols of closure of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. These 2 protocols were performed, by 2 parisian clinical teams, that have now been merged at Necker hospital.

Detailed description

In this protocol, the investigator will include patients who were treated, via maxillo-facial surgery, in their early childhood for a Pierre Robin sequence. In the frame of a follow-up visit, if they accept to participate in the study, they will fulfill with 2 psychologists, 3 quality of life questionnaires, and 1 depression assessment questionnaire. This will aim at evaluate their quality of life and their social integration, at the time of adolescence.

Conditions

• Pierre Robin Syndrome

Interventions

Type	Name	Description
OTHER	Pierre Robin sequence patients	4 questionnaires will be completed by the patient : * "Kidscreen 52" (generic quality of life questionnaire) * "Voice Handicap Index" : VHI-9i (specific quality of life questionnaire) * "Child Oral Health Impact Profile" : COHIP (specific quality of life questionnaire) * "MDI-C" (composite depression scale for minors)

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2017-06-21
• Last updated: 2025-05-06

Locations

1 site across 1 country: France