Clinical trial NCT03671551: Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder
Official title: Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Eating Disorders in Children
Psychomotor Development Impaired
Keywords: Eating Disorders in Children
Psychomotor Development Impaired
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged from 6 to 30 months with eating disorder and adressed by the pediatrician or general practitionner

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.


Eligibility criteria: Inclusion Criteria:

* Age: 6 to 30 months
* Oral disorder defined by a MCH score ≥ 61

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Developmental Quotient
timeFrame: at day 1
Secondary outcomes:
measure: Quotient of development of the posturo-motor skills
timeFrame: 1 day
measure: Development Quotient for the Brunet Lézine Coordination Subcategory
timeFrame: 1 day
measure: Developmental Quotient for Brunet Lézine Language Subcategory
timeFrame: 1 day
measure: Development Quotient for the Brunet Lézine Socialization Subcategory
timeFrame: 1 day
measure: tactile irritability
timeFrame: 1 day
measure: irritant irritability
timeFrame: 1 day
measure: Observation of attachment
timeFrame: 1 day
measure: Attachment with grandparent / parent
timeFrame: 1 day
measure: Food difficulty score child eating behavior questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
state: Ile De France
city: Créteil
country: France
facility: CHI Creteil
Study officials:
affiliation: CHI Créteil
name: Camille JUNG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.