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

NCT ID: NCT04536974

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2024-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition, Child

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SEFI tool

Detect the risk of malnutrition with the SEFI tool

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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®
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gauthier Foulon, Doctor

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Angers

Angers, , France

Site Status RECRUITING

APHP Trousseau Paris University Hospital

Paris, , France

Site Status RECRUITING

Rennes University Hospital

Rennes, , France

Site Status RECRUITING

CHU Toulouse

Toulouse, , France

Site Status RECRUITING

Tours University Hospital

Tours, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

cecile ferragu

Role: CONTACT

0299282555

Direction de la Recherche et de l'Innovation

Role: CONTACT

0299282555

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emilie CHAILLOU, Dr

Role: primary

Béatrice Dubern, professor

Role: primary

Ronan Thibault, Doctor

Role: primary

Emmanuel MAS, Dr

Role: primary

Arnaud De LUCA, Doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A00739-30

Identifier Type: OTHER

Identifier Source: secondary_id

35RC20_3019_SEFI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.