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

Malnutrition, Child Clinical Trial

— SEFI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536974
• Other study ID #: 35RC20_3019_SEFI
• Secondary ID: 2020-A00739-30
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: June 18, 2024

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: cecile ferragu
• Phone: 0299282555
• Email: cecile.ferragu[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: June 18, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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®

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Diagnostic Test:
• SEFI tool
Detect the risk of malnutrition with the SEFI tool

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	APHP Trousseau Paris University Hospital	Paris
France	Rennes University Hospital	Rennes
France	CHU Toulouse	Toulouse
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	reliability of SEFI ® to detect the risk of chronic undernutrition 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: Weight to Age ratio and Height to Age ratio	6 months
Secondary	feasibility of SEFI®	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
Secondary	correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay	Duration of hospitalization and complications during hospitalization	9 months