NCT04536974

Brief Summary

The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
680

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

August 28, 2020

Last Update Submit

May 2, 2023

Conditions

Keywords

MALNUTRITIONCHILDRENSEFI

Outcome Measures

Primary Outcomes (1)

  • Assess the reliability of SEFI® for detecting the risk of acute malnutrition in pediatrics

    rate of agreement between the diagnoses of malnutrition obtained by the SEFI® tool and those obtained by diagnostic tools already validated in children: the Weight to Height ratio (or Waterlow index)

    6 month

Secondary Outcomes (3)

  • reliability of SEFI ® to detect the risk of chronic undernutrition in pediatrics

    6 months

  • feasibility of SEFI®

    6 months

  • correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay

    9 months

Interventions

SEFI toolDIAGNOSTIC_TEST

Detect the risk of malnutrition with the SEFI tool

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization

You may qualify if:

  • Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization.
  • Whose holders of parental authority have received information on the protocol and have not expressed their opposition to the child's participation in the study,
  • Having received information on the protocol and not having expressed opposition to participating in the study.

You may not qualify if:

  • Patients whose level of understanding does not allow the use of SEFI®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Angers

Angers, 49000, France

RECRUITING

APHP Trousseau Paris University Hospital

Paris, 75012, France

RECRUITING

Rennes University Hospital

Rennes, 35000, France

RECRUITING

CHU Toulouse

Toulouse, 31059, France

RECRUITING

Tours University Hospital

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Gauthier Foulon, Doctor

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Direction de la Recherche et de l'Innovation

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

March 10, 2021

Primary Completion

March 18, 2024

Study Completion

June 18, 2024

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations