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

Imagine Institute

Status: Completed

Conditions: Pierre Robin Syndrome

Treatments: Other: Pierre Robin sequence patients

Study type: Observational

Funder types: Other

Identifiers

NCT03194178

IMIS2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Pierre Robin sequence patients

Description:

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.

Treatment:

Other: Pierre Robin sequence patients