Clinical trial NCT06471842: Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment
Official title: Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inherited Metabolism Disease
Keywords: Inherited Metabolism Disease
Paediatric eating disorders
Dietary treatment
Montreal feeding scale
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Inherited Metabolism Disease (IMD) with dietary treatment planning to come for a hospital visit as part of their standard care.

Brief summary: The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.

Detailed description: Inherited Metabolic Diseases (IMDs) are rare conditions, which are the consequence of a genetic defect affecting an enzyme or a transporter involved in metabolism. This enzymatic defect leads to the accumulation of a potentially toxic compound located upstream of the deficiency and/or the absence of a compound located downstream of the defect. Treatment is possible and it consists of dietary and/or drug treatment.

Pediatric Eating Disorders (PED) cover "all the difficulties of oral feeding. These may be disorders due to absence of spontaneous feeding behavior, or refusal to eat, and disorders which affect the child's entire psychomotor, language and emotional development.

To date, the investigators note the absence of data on the prevalence of PED in IMDs and more generally on the quality of life and psychomotor development of these patients.

The causes and mechanisms of PED are numerous and heterogeneous. Their origins can be endogenous and/or exogenous.

Our main hypothesis is that the presence of PEDs varies depending on the different categories of IMDs with dietary treatment. Estimating their prevalence would enable awareness and early, better quality care.

This study aims to obtain clear and consistent results from a validated scale. It is a single-site study prospectively including patients from the Necker-Enfants Malades hospital reference center.

Parents will be informed of the study by an investigator (psychomotor therapist or dietician) during a phone call, by email or in hospital prior to the inclusion visit.

On the day of inclusion, the parent's and the child's (depending on their age) non-opposition will be collected before carrying out any procedure and recorded in the patient's medical file.

The MCH (Montreal children's hospital) scale and the parental questionnaire will be proposed by the study investigators at the same time, in a physical interview.

The collection of medical data in the patient's file and the rating of the MCH scale will be done in parallel by the study investigators.

Eligibility criteria: Inclusion Criteria:

* Patient from 12 months to 6 years and 11 months old
* Patient with an Inherited Metabolic Diseases with dietary treatment
* Patient having experimented a dietary diversification at least 6 month prior
* Patient whose parents do not object to their participation in the study

Exclusion Criteria:

* Patient with an associated chronic disease
* Patient with diagnosed Autistic Spectrum Disorder (ASD) or Pervasive Developmental Disorders (PDD)
* Patient born before 36 weeks of amenorrhea
* Patient with multiple disabilities
* Patient with dystonia
* Patient with absent or unstable head posture
* Patient whose parents do not fully understand or speak French

Primary outcomes:
measure: Feeding scale score
timeFrame: 1 day
Secondary outcomes:
measure: Disorders severity level differentiation
timeFrame: 1 day
measure: Paediatric eating disorders prevalence for each pathology
timeFrame: 1 day
measure: Risk factors identification
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Enfants Malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Manon Tessier
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
citation: Evans S, Alroqaiba N, Daly A, Neville C, Davies P, Macdonald A. Feeding difficulties in children with inherited metabolic disorders: a pilot study. J Hum Nutr Diet. 2012 Jun;25(3):209-16. doi: 10.1111/j.1365-277X.2012.01229.x. Epub 2012 Feb 9.
citation: Ouattara A, Resseguier N, Cano A, De Lonlay P, Arnoux JB, Brassier A, Schiff M, Pichard S, Fabre A, Hoebeke C, Guffon N, Fouilhoux A, Broue P, Touati G, Dobbelaere D, Mention K, Labarthe F, Tardieu M, De Parscau L, Feillet F, Bonnemains C, Kuster A, Labrune P, Barth M, Damaj L, Lamireau D, Berbis J, Auquier P, Chabrol B. Individual and Family Determinants for Quality of Life in Parents of Children with Inborn Errors of Metabolism Requiring a Restricted Diet: A Multilevel Analysis Approach. J Pediatr. 2023 Mar;254:39-47.e4. doi: 10.1016/j.jpeds.2022.08.060. Epub 2022 Oct 17.