NCT05157633: OPENING

Oral Exploration of Objects and Food Diversification

Completed Last updated 23 June 2022

What this trial tests

trial testing Controls in Infant Development in 354 participants. Completed in 20 April 2022.

Timeline

15 September 2021

Primary endpoint
20 April 2022

20 April 2022

Quick facts

Lead sponsor	Centre Hospitalier Intercommunal Creteil
Status	Completed
Study type	OBSERVATIONAL
Enrollment	354
Start date	15 September 2021
Primary completion	20 April 2022
Estimated completion	20 April 2022
Sites	1 location across France

Drugs / interventions tested

• Controls

Conditions studied

• Infant Development — all drugs for Infant Development →

Sponsor

Centre Hospitalier Intercommunal Creteil

Who can join

Adults 9 Months to 6, any sex, with Infant Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Oral exploration and food selectivity: A case-control study conducted in a multidisciplinary outpatient setting.
   Bellaïche M, Leblanc V, Viala J, Jung C. · · 2023 · cited 1× · PMID 36873650 · DOI 10.3389/fped.2023.1115787