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Completed

NCT Number: NCT04133038

Evaluation of 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.

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.

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Key information

Age range

9 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatry, Necker-Enfants Malades Hospital

Paris, 75015, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire

Other

Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Filiere de Sante Maladies Rares TETECOU
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST

Acronym: ORALQUEST

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2019
Registry last updated
Dec 16, 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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