Evaluation of ORALQUEST

NCT04133038 | Completed

• 2 other identifiers: APHP1907902019-A01215-52
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding and Eating Disorders of Childhood

Keywords

Feeding disorders; Eating disorders; Evaluation

Outcome Measures

Primary Outcomes (1)

• Validity of ORALQUEST questionnaire

  Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.

  1 month

Secondary Outcomes (5)

• ORALQUEST global score

  1 day

• Behaviour during the meal ORALQUEST Sub-score

  1 day

• Oromotor skills ORALQUEST Sub-score

  1 day

• Sensory sensitivity ORALQUEST Sub-score

  1 day

• Familial environment ORALQUEST Sub-score

  1 day

Study Arms (8)

Children consulting

Children consulting in the expert center for food difficulties.

Other: Questionnaire

Pierre Robin sequence

Children with Pierre Robin sequence following for food difficulties.

Other: Questionnaire

Cardiac malformations

Children with cardiac malformations followed for food difficulties.

Other: Questionnaire

Oesophageal atresia

Children with oesophageal atresia followed for food difficulties.

Other: Questionnaire

Cleft lip and palate

Children with cleft lip and palate followed for food difficulties.

Other: Questionnaire

Autism spectrum disorders

Children followed for congenital pathology that cause food difficulties.

Other: Questionnaire

Ex-prematurity < 32 AG

Children born premature followed for food difficulties.

Other: Questionnaire

Chromosomal anomalies

Children with chromosomal anomalies followed for food difficulties.

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Autism spectrum disorders; Cardiac malformations; Children consulting; Chromosomal anomalies; Cleft lip and palate; Ex-prematurity < 32 AG; Oesophageal atresia; Pierre Robin sequence

Eligibility Criteria

• Age: 9 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Filiere de Sante Maladies Rares TETECOU: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Department of Pediatry, Necker-Enfants Malades Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood; Feeding and Eating Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Véronique ABADIE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 21, 2019
• Study Start: March 3, 2020
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)