Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482218
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-07-17
Brief Title:
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
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 investigators 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 investigators 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:
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