NCT04482218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

July 17, 2020

Last Update Submit

December 28, 2020

Conditions

Keywords

NutritionAntromopemtric dataPediatry

Outcome Measures

Primary Outcomes (1)

  • Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology

    Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology

    2 month

Secondary Outcomes (1)

  • Identified profiles of children who do match between the two diagnostics methods

    2 month

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Parental or child opposition
  • Legal guardian unable to express consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Antoine AVIGNON, PR

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

July 17, 2020

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations