Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04482218
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations
Status:
COMPLETED
Status Verified Date:
2020-12
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:
EDEN
Brief Summary:
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.
Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.
Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.
The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.
The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.
Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.
Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.
The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.
The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.
Detailed Description:
The investigators will conduct a prospective cohort without change in care.
Following classic patient admission in involved departments, the investigating team moves to the department to collect data.
The measurements and informations collected are no different from those taken in the context of normal care.
All anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.
With collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.
For any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.
Data collected are as follows:
Simple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.
Assessment of ingesta. A non-opposition will be asked
Following classic patient admission in involved departments, the investigating team moves to the department to collect data.
The measurements and informations collected are no different from those taken in the context of normal care.
All anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.
With collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.
For any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.
Data collected are as follows:
Simple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.
Assessment of ingesta. A non-opposition will be asked
Study Oversight
Has Oversight DMC:
False
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?: