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Evaluation of ORALQUEST (ORALQUEST)

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ClinicalTrials.gov Identifier: NCT04133038
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : December 7, 2021
Sponsor:
Collaborators:
Filiere de Sante Maladies Rares TETECOU
URC-CIC Paris Descartes Necker Cochin
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Feeding and Eating Disorders of Childhood Other: Questionnaire

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
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Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Groups and Cohorts
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Group/Cohort Intervention/treatment
Children consulting
Children consulting in the expert center for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Pierre Robin sequence
Children with Pierre Robin sequence following for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Cardiac malformations
Children with cardiac malformations followed for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Oesophageal atresia
Children with oesophageal atresia followed for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Cleft lip and palate
Children with cleft lip and palate followed for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Autism spectrum disorders
Children followed for congenital pathology that cause food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Ex-prematurity < 32 AG
Children born premature followed for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Chromosomal anomalies
Children with chromosomal anomalies followed for food difficulties.
 Other: Questionnaire
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ORALQUEST global score [ Time Frame: 1 day ]
    ORALQUEST global score in each of the 8 cohorts of children

  2. Behaviour during the meal ORALQUEST Sub-score [ Time Frame: 1 day ]
    ORALQUEST sub-score in each of the 8 cohorts of children

  3. Oromotor skills ORALQUEST Sub-score [ Time Frame: 1 day ]
    ORALQUEST sub-score in each of the 8 cohorts of children

  4. Sensory sensitivity ORALQUEST Sub-score [ Time Frame: 1 day ]
    ORALQUEST sub-score in each of the 8 cohorts of children

  5. Familial environment ORALQUEST Sub-score [ Time Frame: 1 day ]
    ORALQUEST sub-score in each of the 8 cohorts of children


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 9 months to 6 years with or without a congenital disease with a phobic and selective eating behaviour.
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- parent (s) with a low level of French to understand the questions

Contacts and Locations
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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): NCT04133038


Contacts
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Contact: Véronique ABADIE, MD, PhD +33 (0)1 44 49 52 11 veronique.abadie@aphp.fr
Contact: Prissile BAKOUBOULA, PhD +33 1 71 19 64 94 prissile.bakouboula@aphp.fr

Locations
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France
Department of Pediatry, Necker-Enfants Malades Hospital Recruiting
Paris, France, 75015
Contact: Véronique ABADIE, MD, PhD    +33 (0)1 44 49 52 11    veronique.abadie@aphp.fr   
Sub-Investigator: Béatrice THOUVENIN, psychologist         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Filiere de Sante Maladies Rares TETECOU
URC-CIC Paris Descartes Necker Cochin
Investigators
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Principal Investigator: Véronique ABADIE, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04133038    
Other Study ID Numbers: APHP190790
2019-A01215-52 ( Registry Identifier: ID-RCB )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Feeding disorders
Eating disorders
Evaluation
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Feeding and Eating Disorders of Childhood
Mental Disorders