Pierre Robin SyndromeADOROBINNCT03194178
Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence
An observational study of Pierre Robin Syndrome, run by Imagine Institute at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pierre Robin Syndrome
- What is being tested?
- Pierre Robin sequence patients
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pierre Robin Syndrome
- Being tested
- Pierre Robin sequence patients
- Medical subject headings
- Pierre Robin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pierre Robin sequence patientsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pierre Robin sequence patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 3 years
Secondary outcomes (4)
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
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)
Measured: 3 years
Comparison of the results of the 2 surgical protocols on the maxillo-mandibular growth
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.
Measured: 3 years
Comparison of the results of the 2 surgical protocols on the phonatory aftereffects
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.
Measured: 3 years
Need of secondary surgery
The investigators will assess the need to realize a secondary surgery, according the initial surgery protocol used.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startJul 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pierre Robin SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Abadie, Pr, Principal investigator, Necker - Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194178
- Sponsor's protocol ID
- IMIS2016-01
- Acronym
- ADOROBIN
- Status last verified
- May 2025
- First submitted
- 9 Jun 2017
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence
- ClinicalTrials.gov ID
- NCT03194178
- Acronym / sponsor ID
- ADOROBIN / IMIS2016-01
- Conditions
- Pierre Robin Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pierre Robin sequence patients | – | Other: Pierre Robin sequence patientsPatients 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pierre Robin sequence patients4 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) | Other | Pierre Robin sequence patients |
Primary outcome
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.
4 secondary outcomes
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
Comparison of the results of the 2 surgical protocols on the maxillo-mandibular growth
Time frame: 3 years
Comparison of the results of the 2 surgical protocols on the phonatory aftereffects
Time frame: 3 years
Need of secondary surgery
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pierre Robin Syndrome
Active, not recruitingObservational study
3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence
Pierre Robin Sequence (PRS), Difficult Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Abadie, Pr principal investigator
Necker - Enfants Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pierre Robin Syndrome, run by Imagine Institute at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.