Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence (ADOROBIN)
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|ClinicalTrials.gov Identifier: NCT03194178|
Recruitment Status : Unknown
Verified September 2018 by Imagine Institute.
Recruitment status was: Recruiting
First Posted : June 21, 2017
Last Update Posted : September 26, 2018
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.
|Condition or disease||Intervention/treatment|
|Pierre Robin Syndrome||Other: Pierre Robin sequence patients|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Pierre Robin sequence patients
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 :
- 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 [ Time Frame: 3 years ]
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.
- 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 [ Time Frame: 3 years ]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)
- Comparison of the results of the 2 surgical protocols on the maxillo-mandibular growth [ Time Frame: 3 years ]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.
- Comparison of the results of the 2 surgical protocols on the phonatory aftereffects [ Time Frame: 3 years ]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.
- Need of secondary surgery [ Time Frame: 3 years ]The investigators will assess the need to realize a secondary surgery, according the initial surgery protocol used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194178
|Contact: Véronique Abadie, Premail@example.com|
|Necker - Enfants Malades hospital||Recruiting|
|Contact: Véronique Abadie, Pr firstname.lastname@example.org|
|Principal Investigator: Véronique Abadie|
|Principal Investigator:||Véronique Abadie, Pr||Necker - Enfants Malades Hospital|