Clinical trial NCT03194178: Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence
Official title: Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pierre Robin Syndrome
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
measure: Comparison of the results of the 2 surgical protocols on the maxillo-mandibular growth
timeFrame: 3 years
measure: Comparison of the results of the 2 surgical protocols on the phonatory aftereffects
timeFrame: 3 years
measure: Need of secondary surgery
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades hospital
Study officials:
affiliation: Necker - Enfants Malades Hospital
name: Véronique Abadie, Pr
role: PRINCIPAL_INVESTIGATOR
References: