Eating DisordersPreoraNCT05909787
Prevalence of Oral Disorders in Children in ENT Pathologies
A study testing Auto-questionnaire in people with Eating Disorders and Language Disorders, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Eating Disorders, Language Disorders
- What is being tested?
- Auto-questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Nov 2023
- Phase
- Interventional
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients consulting at ENT departement Robert Debré Hospital
- Age 0-17 years
- Parents and children informed and given their oral consent for the study and speaking french
Who cannot join
- Refusal of parents/children to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Oral Disorders in Children Identified by Parents in the Context of ENT Pathologies
Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score > 70).
Read the detailed description
Over a period of inclusion of 3 months, the doctors of the departement ONT, Robert Debré Hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. After a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.
- Conditions
- Eating Disorders, Language Disorders
- Being tested
- Auto-questionnaire
- Keywords
- Eating disorders, Language disorders, Childhood
- Medical subject headings
- Feeding and Eating Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-questionnaireOther
MCH (Montreal Children's Hospital) self questionnaire completed by the parents
| Study group | Role | What they receive |
|---|---|---|
| Auto-questionnaire MCH (Montreal Children's Hospital) | Experimental | Auto-questionnaire MCH (Montreal Children's Hospital) Receives: Other: Auto-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty in feeding
MCH self questionnaire / HME score
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natacha TEISSIER, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909787
- Sponsor's protocol ID
- APHP230191
- Other IDs
- IDRCB: 2023-A00201-44
- Acronym
- Preora
- Status last verified
- Apr 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Disorders in Children Identified by Parents in the Context of ENT Pathologies
- ClinicalTrials.gov ID
- NCT05909787
- Acronym / sponsor ID
- Preora / APHP230191
- Conditions
- Eating Disorders, Language Disorders
- Keywords
- Eating disorders, Language disorders, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score > 70).
Detailed description
Over a period of inclusion of 3 months, the doctors of the departement ONT, Robert Debré Hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. After a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auto-questionnaire MCH (Montreal Children's Hospital) | Experimental | Other: Auto-questionnaireAuto-questionnaire MCH (Montreal Children's Hospital) |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients consulting at ENT departement Robert Debré Hospital
- Age 0-17 years
- Parents and children informed and given their oral consent for the study and speaking french
Key exclusion criteria (1 listed)
- Refusal of parents/children to participate
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 |
|---|---|---|
| Auto-questionnaireMCH (Montreal Children's Hospital) self questionnaire completed by the parents | Other | Auto-questionnaire MCH (Montreal Children's Hospital) |
Primary outcome
Difficulty in feeding
Time frame: 50 minutes
MCH self questionnaire / HME score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Natacha TEISSIER, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Auto-questionnaire in people with Eating Disorders and Language Disorders, run by Assistance Publique - Hôpitaux de Paris.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha TEISSIER, PhD (+331 40 03 53 67, natacha.teissier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty in feeding (time frame: 50 minutes). 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 18 Jun 2023.