Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-01 @ 1:53 PM
Study NCT ID:
NCT03671551
Status:
TERMINATED
Last Update Posted:
2019-11-29
First Post:
2018-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Developmental Quotient', 'timeFrame': 'at day 1', 'description': 'Developmental Quotient at Brunet Lézine revised'}], 'secondaryOutcomes': [{'measure': 'Quotient of development of the posturo-motor skills', 'timeFrame': '1 day', 'description': 'Quotient of development of the posturo-motor subcategory with revised Brunet Lézine'}, {'measure': 'Development Quotient for the Brunet Lézine Coordination Subcategory', 'timeFrame': '1 day', 'description': 'Development Quotient for the Brunet Lézine Coordination Subcategory'}, {'measure': 'Developmental Quotient for Brunet Lézine Language Subcategory', 'timeFrame': '1 day', 'description': 'Developmental Quotient for Brunet Lézine Language Subcategory'}, {'measure': 'Development Quotient for the Brunet Lézine Socialization Subcategory', 'timeFrame': '1 day', 'description': 'Development Quotient for the Brunet Lézine Socialization Subcategory'}, {'measure': 'tactile irritability', 'timeFrame': '1 day', 'description': 'Rating on the evaluation grid with tactile irritability'}, {'measure': 'irritant irritability', 'timeFrame': '1 day', 'description': 'Scorecard score at irritant irritability'}, {'measure': 'Observation of attachment', 'timeFrame': '1 day', 'description': 'Score at the grid observation of attachment lines before, during and after the separation of the child'}, {'measure': 'Attachment with grandparent / parent', 'timeFrame': '1 day', 'description': 'Terms of Description of Grandparent / Parent and Parent / Child Attachment by Qualitative Analysis to Semi-directed Issues on Attachment'}, {'measure': 'Food difficulty score child eating behavior questionnaire', 'timeFrame': '1 day', 'description': 'Food difficulty score child eating behavior questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eating Disorders in Children', 'Psychomotor Development Impaired'], 'conditions': ['Eating Disorders in Children', 'Psychomotor Development Impaired']}, 'referencesModule': {'references': [{'pmid': '21495054', 'type': 'BACKGROUND', 'citation': "Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14."}, {'pmid': '25644130', 'type': 'BACKGROUND', 'citation': 'Cardona Cano S, Tiemeier H, Van Hoeken D, Tharner A, Jaddoe VW, Hofman A, Verhulst FC, Hoek HW. Trajectories of picky eating during childhood: A general population study. Int J Eat Disord. 2015 Sep;48(6):570-9. doi: 10.1002/eat.22384. Epub 2015 Jan 30.'}, {'pmid': '27133367', 'type': 'BACKGROUND', 'citation': 'Dubedout S, Cascales T, Mas E, Bion A, Vignes M, Raynaud JP, Olives JP. [Feeding disorders in infants and toddlers: At-risk situations and predisposing factors]. Arch Pediatr. 2016 Jun;23(6):570-6. doi: 10.1016/j.arcped.2016.03.015. Epub 2016 Apr 25. French.'}, {'pmid': '25560449', 'type': 'BACKGROUND', 'citation': 'Kerzner B, Milano K, MacLean WC Jr, Berall G, Stuart S, Chatoor I. A practical approach to classifying and managing feeding difficulties. Pediatrics. 2015 Feb;135(2):344-53. doi: 10.1542/peds.2014-1630. Epub 2015 Jan 5.'}, {'pmid': '21683562', 'type': 'BACKGROUND', 'citation': 'Le Heuzey MF. [Child food refusal: when will we call a child psychiatrist?]. Arch Pediatr. 2011 Aug;18(8):917-20. doi: 10.1016/j.arcped.2011.05.014. Epub 2011 Jun 16. French.'}, {'pmid': '20654855', 'type': 'BACKGROUND', 'citation': 'Issanchou S, Nicklaus S. [Early determinants of food behaviour]. Arch Pediatr. 2010 Jun;17(6):713-4. doi: 10.1016/S0929-693X(10)70073-7. No abstract available. French.'}, {'pmid': '26459321', 'type': 'BACKGROUND', 'citation': 'Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.'}]}, 'descriptionModule': {'briefSummary': 'Dietary difficulties and eating disorders of the child are a common reason for consulting infants and young children. There is currently little data on the psychomotor development of these children and their association with parent-child attachment. The objective of this study is to evaluate, at the same time, the three physiological, psychomotor and attachment dimensions of children with eating disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children aged from 6 to 30 months with eating disorder and adressed by the pediatrician or general practitionner', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 6 to 30 months\n* Oral disorder defined by a MCH score ≥ 61\n\nExclusion Criteria:\n\n* Children in enteral nutrition asked for an indication other than oral disorders\n* Children followed for serious chronic organic pathology causing disorders of the oral (DNTC, swallowing disorders, etc.)\n* Child already assessed by the psychomotrician who participated in the study\n* Placement of the child in a medical institution or in a foster family.\n* Parents' refusal to participate in the study\n* Establishment of a psychomotor follow-up between the time of the medical consultation and the psychomotor evaluation."}, 'identificationModule': {'nctId': 'NCT03671551', 'acronym': 'TODEVA', 'briefTitle': 'Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder', 'orgStudyIdInfo': {'id': 'TODEVA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psychomotor/psychological evaluation', 'description': 'Children in the study aged 6 to 30 months followed or referred to CHIC for oral disorders will have a psychomotor assessment and a psychological interview. Questionnaires on eating behavior will also be proposed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHI Creteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CHI Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Camille JUNG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHI Créteil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Camille JUNG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of the clinical research department', 'investigatorFullName': 'Camille JUNG', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}