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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03671551
Other study ID # TODEVA
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 19, 2018
Est. completion date November 20, 2019

Study information

Verified date November 2019
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 20, 2019
Est. primary completion date November 20, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 30 Months
Eligibility 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.

Study Design


Locations

Country Name City State
France CHI Creteil Créteil
France CHI Créteil Créteil Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Camille JUNG

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. French. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Developmental Quotient Developmental Quotient at Brunet Lézine revised at day 1
Secondary Quotient of development of the posturo-motor skills Quotient of development of the posturo-motor subcategory with revised Brunet Lézine 1 day
Secondary Development Quotient for the Brunet Lézine Coordination Subcategory Development Quotient for the Brunet Lézine Coordination Subcategory 1 day
Secondary Developmental Quotient for Brunet Lézine Language Subcategory Developmental Quotient for Brunet Lézine Language Subcategory 1 day
Secondary Development Quotient for the Brunet Lézine Socialization Subcategory Development Quotient for the Brunet Lézine Socialization Subcategory 1 day
Secondary tactile irritability Rating on the evaluation grid with tactile irritability 1 day
Secondary irritant irritability Scorecard score at irritant irritability 1 day
Secondary Observation of attachment Score at the grid observation of attachment lines before, during and after the separation of the child 1 day
Secondary Attachment with grandparent / parent Terms of Description of Grandparent / Parent and Parent / Child Attachment by Qualitative Analysis to Semi-directed Issues on Attachment 1 day
Secondary Food difficulty score child eating behavior questionnaire Food difficulty score child eating behavior questionnaire 1 day
See also
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