Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Pierre Robin Syndrome Other: Pierre Robin sequence patients

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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 :

  • "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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Véronique Abadie, Pr veronique.abadie@aphp.fr

Locations
Layout table for location information
France
Necker - Enfants Malades hospital Recruiting
Paris, France
Contact: Véronique Abadie, Pr       veronique.abadie@aphp.fr   
Principal Investigator: Véronique Abadie         
Sponsors and Collaborators
Imagine Institute
Investigators
Layout table for investigator information
Principal Investigator: Véronique Abadie, Pr Necker - Enfants Malades Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT03194178    
Other Study ID Numbers: IMIS2016-01
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pierre Robin Syndrome
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
 Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities