CHU Robert Debré, 48 Bd Sérurier
Paris, 75019, France
NCT Number: NCT05157633
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).
Looking for future studies?
Notify Me9 month–6 year
All sexes
Observational
Paris, 75019, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
For patients and controls:
questionnaire food scale: HME data collection of food survey
Time frame: 1 day
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
Time frame: 1 day
Number of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.
Time frame: 1 day
Percentage of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.
Time frame: 1 day
Number of children with an inability to touch certain non-food textures and an inability to orally explore objects by a qualitative questionnaire without score not validated
Time frame: 1 day
percentage of children with an inability to touch certain non-food textures and an inability to orally explore objects
Time frame: 1 day
Number and percentage of children who have crawled in their psychomotor development
Time frame: 1 day
Number of children who orally explored the objects
Time frame: 1 day
percentage of children who orally explored the objects
Time frame: 1 day
Number of children with constipation according to ROME IV criteria
Time frame: 1 day
percentage of children with constipation according to ROME IV criteria
Centre Hospitalier Intercommunal Creteil
Other
Acronym: OPENING
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04454645
Chemically-Induced Disorders, Infant Development
Newark, Delaware, United States
View Trial DetailsNCT06053515
Depression, Postpartum, Depressive Disorder
College Park, Maryland, United States
View Trial DetailsNCT05793112
Food Protein Induced Allergic Proctocolitis, Gut Microbiome
Newton, Massachusetts, United States
View Trial DetailsNCT06230848
Infant Development, Stress
Maywood, Illinois, United States
View Trial Details