Clinical trial NCT05157633: Oral Exploration of Objects and Food Diversification
Official title: Oral Exploration of Objects and Food Diversification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: Infants and children with eating difficulties
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 354
Sex: ALL
Minimum age (years): 9
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with eating difficulties and children from nurseries without eating difficulties (controls).

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.

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.

Exclusion Criteria:

Exclusion of controls who have:

* an eating disorder defined by an MCH score\> = 61 (score defined for the inclusion criteria)
* encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)

For patients and controls:

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

Primary outcomes:
measure: Number of participants with a delay or lack of acquisition of oral exploration of objects.
timeFrame: 1 day
Secondary outcomes:
measure: To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
timeFrame: 1 day
measure: To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
timeFrame: 1 day
measure: To determine if there is a link between the inability to orally explore objects and the inability to touch certain non-food textures
timeFrame: 1 day
measure: To determine if there is a link between a link between the inability to orally explore objects. And the inability to touch certain non-food textures
timeFrame: 1 day
measure: To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
timeFrame: 1 day
measure: To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
timeFrame: 1 day
measure: To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
timeFrame: 1 day
measure: To determine if there is a link between an incidence of constipation in both groups of children
timeFrame: 1 day
measure: To determine if there is a link between an incidence of constipation in both groups of children
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Robert Debré, 48 Bd Sérurier
Study officials:
References: