Oral Exploration of Objects and Food Diversification

NCT05157633 | Completed

• 1 other identifier: OPENING
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

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).

Conditions

Infant Development

Keywords

Infants and children with eating difficulties

Outcome Measures

Primary Outcomes (1)

• Number of participants with a delay or lack of acquisition of oral exploration of objects.

  Deferred presence or absence of the acquisition of the competence of oral exploration of objects between 6 and 10 months by a qualitative questionnaire without score not validated

  1 day

Secondary Outcomes (9)

• 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

  1 day

• 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

  1 day

• To determine if there is a link between the inability to orally explore objects and the inability to touch certain non-food textures

  1 day

• 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

  1 day

• 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.

  1 day

Study Arms (2)

Controls

Children without eating difficulties

Other: Controls

Patients

Children with eating difficulties

Interventions

Controls OTHER

questionnaire food scale: HME data collection of food survey

Controls

Eligibility Criteria

• Age: 9 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with eating difficulties and children from nurseries without eating difficulties (controls).

You may qualify if:

• 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.

You may not qualify if:

• encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)
• For patients and controls:
• Encephalopathies
• Neuro-metabolic disorders
• Suspected or identified genetic syndromes

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHU Robert Debré, 48 Bd Sérurier

Paris, 75019, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: December 15, 2021
• Study Start: September 15, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)