Feeding and Eating Disorders of ChildhoodORALQUESTNCT04133038
Evaluation of ORALQUEST
An observational study of Feeding and Eating Disorders of Childhood, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. Read more about this study
- Who is it for?
- Ages 9 months to 6 years
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Questionnaire
- How many people
- 338 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2020to 28 Jul 2023
- 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 9 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 9 months to 6 years with or without a congenital disease with a phobic and selective eating behaviour.
Who may be able to join
- child of 9 months to 6 years old:
- Consulting for food difficulties in the expert center for phobic and selective eating behaviour of Necker-Enfants malades hospital or
- Followed to Necker-Enfants Malades hospital for one of 7 chronic congenital pathologies: oesophageal atresia, cardiac malformations, Pierre Robin sequence, cleft lip and palate, autism spectrum disorders, ex-prematurity < 32 AG, chromosomal anomalies
Who cannot join
- parent (s) with a low level of French to understand the questions
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Pediatry, Necker-Enfants Malades Hospital
Paris, 75015
About this study
Official title: Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST
Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. In addition to the clinical examination and the instrumental investigation, a parental questionnaire is very useful in assessing these disorders. The questionnaire (testing the right period of age, evaluating the 4 aspects involved in the disorders, translated in French) does not exist. Consequently, the Necker team of the reference center, has built a hetero-questionnaire named ORALQUEST, which analyses 4 dimensions of the feeding and eating disorders of young children from 9 months to 6 years: behaviour, oral motor skills, sensory sensitivity and familial environment.
The objective of the study is to test the metrological qualities of Oralquest in children with congenital chronic diseases including feeding and eating disorders.
Read more
The questionnaire will be proposed to 7 cohorts of children who are followed in Necker for :
- oesophageal atresia,
- cardiac malformations,
- Pierre Robin sequence,
- cleft lip and palate,
- autism spectrum disorders,
- ex-prematurity < 32 AG,
- chromosomal anomalies, and proposed to children consulting in the expert center for phobic and selective eating behaviour.
The analysis of the metrological qualities of the questionnaire include several calculation and specialized methods: inter-rate concordance; test-retest; intrinsic validity, concurrent validity, sensitivity/specificity.
Read the detailed description
Objectives of the study To analyse the properties of a new scale that evaluates feeding and eating disorders of young children. This scale is a hetero-questionnaire that was build by an expert team. It includes 46 questions scored with a Likert scale. These questions identify 4 fields: behaviour during the meal, oromotor skills, sensory sensitivity and familial environment. Each field gives a sub-score, their addition gives a global score
Methods
To evaluate the metrological qualities of this questionnaire, the investigators are going to investigate 300 children followed-up in Necker for either Aversive/restrictive food intake disorders (ARFID) or for chronic congenital disease very often complicated with feeding and eating disorders:
- oesophageal atresia,
- cardiac malformations,
- Pierre Robin sequence,
- cleft lip and palate,
- autism spectrum disorders,
- ex-prematurity < 32 AG,
- chromosomal anomalies,
They want to test the statistical significance of the score. For that, they will test:
- the face validity,
- the structure validity
- and, the internal consistence of Oralquest. The interconcept validity will be analysed by comparing the Oralquest results to the best gold standard tests that are found for each field tested by Oralquest.
For the global score : The screening test : self-questionnaire, the Montreal Children Feeding Scale.
For the behavior score : the symptom check list (items regarding eating). For the oromotor skills : (Schedule for Oral-Motor Assessment) for the children aged 9-24 months and the Oral-Motor Assessment Scale for the children aged 2-6 years).
For the familial environment : The STAI (State Trait Anxiety Inventory).
The reproductibility will be tested by :
- Test-retest
- Inter examiner reproductibility
- sensibility
- specificity
- Being tested
- Questionnaire
- Keywords
- Feeding disorders, Eating disorders, Evaluation
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Children consulting | Children consulting in the expert center for food difficulties. Receives: Other: Questionnaire | |
| Pierre Robin sequence | Children with Pierre Robin sequence following for food difficulties. Receives: Other: Questionnaire | |
| Cardiac malformations | Children with cardiac malformations followed for food difficulties. Receives: Other: Questionnaire | |
| Oesophageal atresia | Children with oesophageal atresia followed for food difficulties. Receives: Other: Questionnaire | |
| Cleft lip and palate | Children with cleft lip and palate followed for food difficulties. Receives: Other: Questionnaire | |
| Autism spectrum disorders | Children followed for congenital pathology that cause food difficulties. Receives: Other: Questionnaire | |
| Ex-prematurity < 32 AG | Children born premature followed for food difficulties. Receives: Other: Questionnaire | |
| Chromosomal anomalies | Children with chromosomal anomalies followed for food difficulties. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of ORALQUEST questionnaire
Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.
Measured: 1 month
Secondary outcomes (5)
ORALQUEST global score
ORALQUEST global score in each of the 8 cohorts of children
Measured: 1 day
Behaviour during the meal ORALQUEST Sub-score
ORALQUEST sub-score in each of the 8 cohorts of children
Measured: 1 day
Oromotor skills ORALQUEST Sub-score
ORALQUEST sub-score in each of the 8 cohorts of children
Measured: 1 day
Sensory sensitivity ORALQUEST Sub-score
ORALQUEST sub-score in each of the 8 cohorts of children
Measured: 1 day
Familial environment ORALQUEST Sub-score
ORALQUEST sub-score in each of the 8 cohorts of children
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start3 Mar 2020
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Filiere de Sante Maladies Rares TETECOU, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Véronique ABADIE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133038
- Sponsor's protocol ID
- APHP190790
- Other IDs
- 2019-A01215-52
- Acronym
- ORALQUEST
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2019
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thouvenin B, Ould-Ammar R, Ouss L, Gavelle P, Disnan G, Royer A, Vegas N, Fraysseix CD, Adnot P, Barbieri V, Hassler C, Elie C, Barry C, Abadie V. Development and validation of the new French ORALQUEST scale for evaluating feeding difficulties in young children. J Pediatr Gastroenterol Nutr. 2026 Jun 22. doi: 10.1002/jpn3.70491. Online ahead of print.
PubMed 42324958
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST
- ClinicalTrials.gov ID
- NCT04133038
- Acronym / sponsor ID
- ORALQUEST / APHP190790
- Keywords
- Feeding disorders, Eating disorders, Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Filiere de Sante Maladies Rares TETECOU, URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 21 Oct 2019 (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.
Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. In addition to the clinical examination and the instrumental investigation, a parental questionnaire is very useful in assessing these disorders. The questionnaire (testing the right period of age, evaluating the 4 aspects involved in the disorders, translated in French) does not exist. Consequently, the Necker team of the reference center, has built a hetero-questionnaire named ORALQUEST, which analyses 4 dimensions of the feeding and eating disorders of young children from 9 months to 6 years: behaviour, oral motor skills, sensory sensitivity and familial environment.
The objective of the study is to test the metrological qualities of Oralquest in children with congenital chronic diseases including feeding and eating disorders.
The questionnaire will be proposed to 7 cohorts of children who are followed in Necker for :
- oesophageal atresia,
- cardiac malformations,
- Pierre Robin sequence,
- cleft lip and palate,
- autism spectrum disorders,
- ex-prematurity < 32 AG,
- chromosomal anomalies, and proposed to children consulting in the expert center for phobic and selective eating behaviour.
The analysis of the metrological qualities of the questionnaire include several calculation and specialized methods: inter-rate concordance; test-retest; intrinsic validity, concurrent validity, sensitivity/specificity.
Detailed description
Objectives of the study To analyse the properties of a new scale that evaluates feeding and eating disorders of young children. This scale is a hetero-questionnaire that was build by an expert team. It includes 46 questions scored with a Likert scale. These questions identify 4 fields: behaviour during the meal, oromotor skills, sensory sensitivity and familial environment. Each field gives a sub-score, their addition gives a global score
Methods
To evaluate the metrological qualities of this questionnaire, the investigators are going to investigate 300 children followed-up in Necker for either Aversive/restrictive food intake disorders (ARFID) or for chronic congenital disease very often complicated with feeding and eating disorders:
- oesophageal atresia,
- cardiac malformations,
- Pierre Robin sequence,
- cleft lip and palate,
- autism spectrum disorders,
- ex-prematurity < 32 AG,
- chromosomal anomalies,
They want to test the statistical significance of the score. For that, they will test:
- the face validity,
- the structure validity
- and, the internal consistence of Oralquest. The interconcept validity will be analysed by comparing the Oralquest results to the best gold standard tests that are found for each field tested by Oralquest.
For the global score : The screening test : self-questionnaire, the Montreal Children Feeding Scale.
For the behavior score : the symptom check list (items regarding eating). For the oromotor skills : (Schedule for Oral-Motor Assessment) for the children aged 9-24 months and the Oral-Motor Assessment Scale for the children aged 2-6 years).
For the familial environment : The STAI (State Trait Anxiety Inventory).
The reproductibility will be tested by :
- Test-retest
- Inter examiner reproductibility
- sensibility
- specificity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Children consulting | – | Other: QuestionnaireChildren consulting in the expert center for food difficulties. |
| Pierre Robin sequence | – | Other: QuestionnaireChildren with Pierre Robin sequence following for food difficulties. |
| Cardiac malformations | – | Other: QuestionnaireChildren with cardiac malformations followed for food difficulties. |
| Oesophageal atresia | – | Other: QuestionnaireChildren with oesophageal atresia followed for food difficulties. |
| Cleft lip and palate | – | Other: QuestionnaireChildren with cleft lip and palate followed for food difficulties. |
| Autism spectrum disorders | – | Other: QuestionnaireChildren followed for congenital pathology that cause food difficulties. |
| Ex-prematurity < 32 AG | – | Other: QuestionnaireChildren born premature followed for food difficulties. |
| Chromosomal anomalies | – | Other: QuestionnaireChildren with chromosomal anomalies followed for food difficulties. |
Who may qualify
- Ages
- 9 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 9 months to 6 years with or without a congenital disease with a phobic and selective eating behaviour.
Key inclusion criteria (3 listed)
- child of 9 months to 6 years old:
- Consulting for food difficulties in the expert center for phobic and selective eating behaviour of Necker-Enfants malades hospital or
- Followed to Necker-Enfants Malades hospital for one of 7 chronic congenital pathologies: oesophageal atresia, cardiac malformations, Pierre Robin sequence, cleft lip and palate, autism spectrum disorders, ex-prematurity < 32 AG, chromosomal anomalies
Key exclusion criteria (1 listed)
- parent (s) with a low level of French to understand the questions
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 |
|---|---|---|
| QuestionnaireParent(s) answering questionnaires about his child's phobic and selective eating behaviour. | Other | Autism spectrum disorders, Cardiac malformations, Children consulting, Chromosomal anomalies, Cleft lip and palate, Ex-prematurity < 32 AG, Oesophageal atresia, Pierre Robin sequence |
Primary outcome
Validity of ORALQUEST questionnaire
Time frame: 1 month
Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.
5 secondary outcomes
ORALQUEST global score
Time frame: 1 day
Behaviour during the meal ORALQUEST Sub-score
Time frame: 1 day
Oromotor skills ORALQUEST Sub-score
Time frame: 1 day
Sensory sensitivity ORALQUEST Sub-score
Time frame: 1 day
Familial environment ORALQUEST Sub-score
Time frame: 1 day
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 25 Aug 2026.
- Results publication: PubMed 42324958Thouvenin B, Ould-Ammar R, Ouss L, Gavelle P, Disnan G, Royer A, Vegas N, Fraysseix CD, Adnot P, Barbieri V, Hassler C, Elie C, Barry C, Abadie V. Development and validation of the new French ORALQUEST scale for evaluating feeding difficulties in young children. J Pediatr Gastroenterol Nutr. 2026 Jun 22. doi: 10.1002/jpn3.70491. Online ahead of print.
- 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.
Véronique ABADIE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Feeding and Eating Disorders of Childhood, run by Assistance Publique - Hôpitaux de Paris 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 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: finished, as of the sponsor's last update on 25 Aug 2026. 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?
Validity of ORALQUEST questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133038, which also lists 1 linked publication.
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 25 Aug 2026.