The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years (SEFI)

May 2, 2023 updated by: Rennes University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Ingesta Easy Assessment Score (SEFI®) (formerly "food intake assessment tool or EPA®") is validated in hospitals in adults to detect the risk of malnutrition and guide nutritional management. SEFI® combines a visual analogue scale (VAS) with a visual assessment of the portions consumed (www.sefi-nutrition.com). It comes in the form of a ruler equipped with a cursor and allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions. consumed (see appendix). A score <7/10 is associated with malnutrition or the risk of malnutrition.

The investigators hypothesize that, in pediatric services for children 10 years of age or older, SEFI® would be a feasible and reliable tool for screening for the risk of malnutrition.

Study Type

Observational

Enrollment (Anticipated)

680

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Recruiting
        • CHU Angers
        • Contact:
          • Emilie CHAILLOU, Dr
      • Paris, France, 75012
        • Recruiting
        • APHP Trousseau Paris University Hospital
        • Contact:
      • Rennes, France, 35000
        • Recruiting
        • Rennes University Hospital
        • Contact:
        • Principal Investigator:
          • Swellen Gastineau
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Emmanuel MAS, Dr
      • Tours, France, 37044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the reliability of SEFI® for detecting the risk of acute malnutrition in pediatrics
Time Frame: 6 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
reliability of SEFI ® to detect the risk of chronic undernutrition in pediatrics
Time Frame: 6 months
rate of agreement between the diagnoses of malnutrition obtained by the SEFI® tool and those obtained by diagnostic tools already validated in children: Weight to Age ratio and Height to Age ratio
6 months
feasibility of SEFI®
Time Frame: 6 months
Percentage of completion of the test compared to the number of subjects included in the study (if the test is carried out for each person included = 100% feasibility)
6 months
correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay
Time Frame: 9 months
Duration of hospitalization and complications during hospitalization
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Gauthier Foulon, Doctor, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

March 18, 2024

Study Completion (Anticipated)

June 18, 2024

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_3019_SEFI
  • 2020-A00739-30 (Other Identifier: French national agency for drugs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition, Child

Clinical Trials on SEFI tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe