Oral Exploration of Objects and Food Diversification

NCT ID: NCT05157633

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 354 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-04-20

Brief Summary

Eating difficulties in infants and young children are defined as all the difficulties in feeding oneself in an appropriate and satisfactory manner. These disorders affect approximately 20 to 25% of infants and young children, and thus constitute one of the most frequent reasons for consultation in these age groups. Many of these children continue to be received in consultation.

Studies show that the lack of intraoral exploration in children could be associated with later difficulties in accepting different textures or new foods. Our clinical examination of sensorimotor functions shows signs of sensory hyper reactivity that are very common in children who always wipe their hands when in contact with food or sticky objects and for those who experience difficulty in brushing or grooming themselves.

In all of the publications available which includes pubmed, there is no mention of the lack of exploration of objects and the stigma of sensory hyper-responsiveness even if this latter was not entirely detailed in the descriptions made.

The trial hypothesis is that this exploration defect corresponds to early sensory hyperreactivity which also plays a deleterious role in the acceptance of new textures and new foods.

In this trial we propose a comparison study with a controlled population of children without eating difficulties as defined by the Montreal MCH score to validate a statistical link between the difficulties in food diversification beyond 18 months and the lack of exploration of the environment with 'mouthing' between 6 and 10 months.

Investigators will analyse consultation questionnaires dedicated to eating difficulties retrospectively (patients) and will compare them with questionnaires of children from daycares without eating difficulties (controls).

Detailed Description

To conduct this study the controls will be recruited from daycares and different nursery schools after agreement with the heads of establishments.

Two questionnaires along with an information note will be distributed to the parents and will be completed in a non-identifying manner, retrieved by the teachers and then sent to the principal investigator.

The questionnaires include the validated Montreal HME questionnaire which will detect the possible existence of eating difficulties and a more general questionnaire on the psychomotor development of the child (not validated because a qualitative questionnaire without a score). The collection of data will be prospective for controls.

Patients on the other hand will be recruited retrospectively from the dedicated oral consultation at the Hospital.

Conditions

Infant Development

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Controls

Children without eating difficulties

Controls

Intervention Type: OTHER

questionnaire food scale: HME data collection of food survey

Patients

Children with eating difficulties

No interventions assigned to this group

Interventions

Controls

questionnaire food scale: HME data collection of food survey

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For patients: Children aged between 9 months and 6 years with eating difficulties defined by the Montreal HME score> = 61.

For controls: children aged between 9 months and 6 years attending a crèche who agreed to participate in the study.

Not opposing participation in the study.

• encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)

For patients and controls:

• Encephalopathies
• Neuro-metabolic disorders
• Suspected or identified genetic syndromes

Exclusion Criteria

Exclusion of controls who have:

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Robert Debré, 48 Bd Sérurier

Paris, , France

Countries

France

Other Identifiers

OPENING

Identifier Type: -

Identifier Source: org_study_id