Study Stopped
Recruitment too low
Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder
TODEVA
1 other identifier
observational
1
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
November 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedNovember 29, 2019
November 1, 2019
1 year
August 8, 2018
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Developmental Quotient
Developmental Quotient at Brunet Lézine revised
at day 1
Secondary Outcomes (9)
Quotient of development of the posturo-motor skills
1 day
Development Quotient for the Brunet Lézine Coordination Subcategory
1 day
Developmental Quotient for Brunet Lézine Language Subcategory
1 day
Development Quotient for the Brunet Lézine Socialization Subcategory
1 day
tactile irritability
1 day
- +4 more secondary outcomes
Study Arms (1)
Psychomotor/psychological evaluation
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.
Eligibility Criteria
children aged from 6 to 30 months with eating disorder and adressed by the pediatrician or general practitionner
You may qualify if:
- Age: 6 to 30 months
- Oral disorder defined by a MCH score ≥ 61
You may not qualify if:
- Children in enteral nutrition asked for an indication other than oral disorders
- Children followed for serious chronic organic pathology causing disorders of the oral (DNTC, swallowing disorders, etc.)
- Child already assessed by the psychomotrician who participated in the study
- Placement of the child in a medical institution or in a foster family.
- Parents' refusal to participate in the study
- Establishment of a psychomotor follow-up between the time of the medical consultation and the psychomotor evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Camille JUNGlead
Study Sites (2)
CHI Creteil
Créteil, 94000, France
CHI Créteil
Créteil, Île-de-France Region, 94000, France
Related Publications (7)
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: 21495054BACKGROUNDCardona 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: 25644130BACKGROUNDDubedout 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: 27133367BACKGROUNDKerzner 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: 25560449BACKGROUNDLe 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: 21683562BACKGROUNDIssanchou 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: 20654855BACKGROUNDQuah 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.
PMID: 26459321BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Camille JUNG, MD
CHI Créteil
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of the clinical research department
Study Record Dates
First Submitted
August 8, 2018
First Posted
September 14, 2018
Study Start
November 19, 2018
Primary Completion
November 20, 2019
Study Completion
November 20, 2019
Last Updated
November 29, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share