Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations

Undernutrition Clinical Trial

— EDEN  

Official title:

Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482218
• Other study ID #: RECHMPL20_0391
• Status: Completed
• Start date: July 17, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion criteria:

• Patient under 18 years old (HAS 2019)

• Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.

Exclusion criteria:

• Parental or child opposition

• Legal guardian unable to express consent

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology	Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology	2 month
Secondary	Identified profiles of children who do match between the two diagnostics methods	Identified profiles of children who do match between the two diagnostics methods	2 month