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

Pierre Robin Syndrome Clinical Trial

— ADOROBIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03194178
• Other study ID #: IMIS2016-01
• Status: Recruiting
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: Imagine Institute
• Contact: Véronique Abadie, Pr
• Email: veronique.abadie[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Having a Pierre Robin sequence, either isolated, either integrated to a collagenopathy, or associated to any other malformation, but without any mental retardation

• Being schooled in normal environment, with a maximum of 2 years of academic delay

• Having being treated, in the early childhood, for a maxillo-facial surgery, either in Paris-Necker or Paris-Trousseau hospitals (1 or 2 step(s) protocols)

Exclusion Criteria:

• Having any other form of Pierre Robin sequence (syndromic or associated to a mental retardation)

• Having more than 2 years of academic delay, or being schooled in a specialized environment

• Having an organic severe intercurrent disease, that could have an impact on the quality of life of the patients.

Related Conditions & MeSH terms

• Pierre Robin Syndrome

Intervention

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)

Locations

Country	Name	City	State
France	Necker - Enfants Malades hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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)	3 years
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	Need of secondary surgery	The investigators will assess the need to realize a secondary surgery, according the initial surgery protocol used.	3 years