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

Recruiting

• Conditions: Malnutrition, Child

• Registration Number: NCT04536974
• Lead Sponsor: Rennes University Hospital

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.

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 Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-03
• Study Start: 2021-03-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-03-18
• Study Completion: 2024-06-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 680

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the reliability of SEFI® for detecting the risk of acute malnutrition in pediatrics	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)

Secondary Outcome Measures

Name	Time	Method
reliability of SEFI ® to detect the risk of chronic undernutrition in pediatrics	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
correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay	9 months	Duration of hospitalization and complications during hospitalization
feasibility of SEFI®	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)

Trial Locations

Locations (5)

Tours University Hospital; 🇫🇷 Tours, France

CHU Toulouse; 🇫🇷 Toulouse, France

Rennes University Hospital; 🇫🇷 Rennes, France

APHP Trousseau Paris University Hospital; 🇫🇷 Paris, France

CHU Angers; 🇫🇷 Angers, France