Malnutrition, ChildSEFINCT04536974
The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years
An observational study of Malnutrition, Child, run by Rennes University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- SEFI tool
- How many people
- 368 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Mar 2021to 8 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization
Who may be able to join
- 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.
Who cannot join
- Patients whose level of understanding does not allow the use of SEFI®
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers, 49000
CHU Montpellier
Montpellier
APHP Trousseau Paris University Hospital
Paris, 75012
Rennes University Hospital
Rennes, 35000
CHU Toulouse
Toulouse, 31059
Tours University Hospital
Tours, 37044
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Child
- Being tested
- SEFI tool
- Keywords
- MALNUTRITION, CHILDREN, SEFI
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEFI toolDiagnostic test
Detect the risk of malnutrition with the SEFI tool
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Secondary outcomes (3)
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
Measured: 6 months
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)
Measured: 6 months
correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay
Duration of hospitalization and complications during hospitalization
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start10 Mar 2021
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gauthier Foulon, Doctor, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536974
- Sponsor's protocol ID
- 35RC20_3019_SEFI
- Other IDs
- 2020-A00739-30
- Acronym
- SEFI
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years
- ClinicalTrials.gov ID
- NCT04536974
- Acronym / sponsor ID
- SEFI / 35RC20_3019_SEFI
- Conditions
- Malnutrition, Child
- Keywords
- MALNUTRITION, CHILDREN, SEFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients whose level of understanding does not allow the use of SEFI®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEFI toolDetect the risk of malnutrition with the SEFI tool | Diagnostic test | – |
Primary outcome
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)
3 secondary outcomes
reliability of SEFI ® to detect the risk of chronic undernutrition in pediatrics
Time frame: 6 months
feasibility of SEFI®
Time frame: 6 months
correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Malnutrition, Child
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruitingPhase 2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauthier Foulon, Doctor principal investigator
Rennes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, Child, run by Rennes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the reliability of SEFI® for detecting the risk of acute malnutrition in pediatrics (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.