Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471842
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-18
Brief Title:
Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEAL
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 andor the absence of a compound located downstream of the defect Treatment is possible and it consists of dietary andor 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 childs 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 andor 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 parents and the childs depending on their age non-opposition will be collected before carrying out any procedure and recorded in the patients medical file
The MCH Montreal childrens 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 patients file and the rating of the MCH scale will be done in parallel by the study investigators
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 childs 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 andor 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 parents and the childs depending on their age non-opposition will be collected before carrying out any procedure and recorded in the patients medical file
The MCH Montreal childrens 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 patients file and the rating of the MCH scale will be done in parallel by the study investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00172-45 | OTHER | None | None |