Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-01 @ 12:39 AM
Study NCT ID:
NCT05157633
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Exploration of Objects and Food Diversification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a delay or lack of acquisition of oral exploration of objects.', 'timeFrame': '1 day', 'description': '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'}], 'secondaryOutcomes': [{'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', 'description': 'Number of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.'}, {'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', 'description': 'Percentage of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.'}, {'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', 'description': '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'}, {'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', 'description': 'percentage of children with an inability to touch certain non-food textures and an inability to orally explore objects'}, {'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', 'description': 'Number and percentage of children who have crawled in their psychomotor development'}, {'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', 'description': 'Number of children who orally explored the objects'}, {'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', 'description': 'percentage of children who orally explored the objects'}, {'measure': 'To determine if there is a link between an incidence of constipation in both groups of children', 'timeFrame': '1 day', 'description': 'Number of children with constipation according to ROME IV criteria'}, {'measure': 'To determine if there is a link between an incidence of constipation in both groups of children', 'timeFrame': '1 day', 'description': 'percentage of children with constipation according to ROME IV criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infants and children with eating difficulties'], 'conditions': ['Infant Development']}, 'descriptionModule': {'briefSummary': "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.\n\nStudies 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.\n\nIn 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.\n\nThe 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.\n\nIn 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.\n\nInvestigators will analyse consultation questionnaires dedicated to eating difficulties retrospectively (patients) and will compare them with questionnaires of children from daycares without eating difficulties (controls).", 'detailedDescription': 'To conduct this study the controls will be recruited from daycares and different nursery schools after agreement with the heads of establishments.\n\nTwo 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.\n\nThe 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.\n\nPatients on the other hand will be recruited retrospectively from the dedicated oral consultation at the Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '9 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with eating difficulties and children from nurseries without eating difficulties (controls).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patients: Children aged between 9 months and 6 years with eating difficulties defined by the Montreal HME score\\> = 61.\n\nFor controls: children aged between 9 months and 6 years attending a crèche who agreed to participate in the study.\n\nNot opposing participation in the study.\n\nExclusion Criteria:\n\nExclusion of controls who have:\n\n* an eating disorder defined by an MCH score\\> = 61 (score defined for the inclusion criteria)\n* encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)\n\nFor patients and controls:\n\n* Encephalopathies\n* Neuro-metabolic disorders\n* Suspected or identified genetic syndromes'}, 'identificationModule': {'nctId': 'NCT05157633', 'acronym': 'OPENING', 'briefTitle': 'Oral Exploration of Objects and Food Diversification', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Oral Exploration of Objects and Food Diversification', 'orgStudyIdInfo': {'id': 'OPENING'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'Children without eating difficulties', 'interventionNames': ['Other: Controls']}, {'label': 'Patients', 'description': 'Children with eating difficulties'}], 'interventions': [{'name': 'Controls', 'type': 'OTHER', 'description': 'questionnaire food scale: HME data collection of food survey', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Robert Debré, 48 Bd Sérurier', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}