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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy and Safety Study of Palovarotene for the Treatment of MO

NCT03442985

Exostoses, Multiple Hereditary

TERMINATED PHASE2

A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

NCT01750957

Fragile X Syndrome

COMPLETED PHASE2

A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation

NCT06789913

RECRUITING PHASE2

A Study of RO4917523 in Patients With Fragile X Syndrome

NCT01517698

Fragile X Syndrome

COMPLETED PHASE2

In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects

NCT02521792

Fibrodysplasia Ossificans Progressiva

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pierre Robin Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Pierre Robin sequence patients

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No