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NCT Number: NCT03194178

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

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.

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Key information

Conditions

Pierre Robin Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker - Enfants Malades hospital

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pierre Robin sequence patients

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: ADOROBIN

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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