An observational study in Pierre Robin Syndrome, sponsored by Imagine Institute. Completed at 1 site in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Imagine Institute · Observational
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.
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.
Patient included will be patients affected with Pierre Robin sequence, and coming at the study reference center in the frame of a routine follow-up visit.
Exclusion Criteria:
Patients presenting a Pierre Robin sequence, and who have been cared in their early childhood by either the Necker or Trousseau hospitals teams, and who are between 12 and 18 years old at the beginning of the study.
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)
Correlation between generic and specific quality of life of the patients, scored via the questionnaires, and the severity of the troubles (facial and phonatory), assessed by the physicians
The data obtained via the 4 quality of life questionnaires will be assessed on regards of the severity of the facial dysmorphy and phonatory disorders. The investigators will aggregate these results, and will be able to check if there is a clear correlation between them. They will be able to say if it can be concluded that the physical troubles due to the Pierre Robin sequence affect the quality of life of the patients.
Time frame: 3 years
Comparison of the generic quality of life of patients with Pierre Robin sequence, scored via the "Kidscreen 52" questionnaire, with the data of the general population
The investigator will assess the generic quality of life of the study patients, scored via the "Kidscreen 52" questionnaire, on regards of general population (data of the literature)
Time frame: 3 years
Comparison of the results of the 2 surgical protocols on the maxillo-mandibular growth
The investigator will compare the long-term maxillo-mandibular growth of the "Pierre Robin" patients, compared to the general population, and compared between the 2 surgical protocols used.
Time frame: 3 years
Comparison of the results of the 2 surgical protocols on the phonatory aftereffects
The investigator will compare the phonatory aftereffects of the "Pierre Robin" patients, compared to the general population, and compared between the 2 surgical protocols used.
Time frame: 3 years
Need of secondary surgery
The investigators will assess the need to realize a secondary surgery, according the initial surgery protocol used.
Time frame: 3 years
Plan to share: No
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Pierre Robin Syndrome
Imagine Institute