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

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

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 18 admitted for hospitalization in the pediatric deparment of the Montpellier University Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology	Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology	2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Antoine AVIGNON, PR, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition; Pediatry; Antromopemtric data
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: RECHMPL20_0391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No