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AzTrials

Child MalnutritionCESARNCT05726422

Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study

An observational study of Child Malnutrition, run by University Hospital, Montpellier at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In hospitalized children, undernutrition increases the length of hospitalization, aggravates the causal pathology, favors the occurrence of complications, and increases the cost of hospitalization. With a prevalence of 10 to 20%, undernutrition is therefore a major problem which, moreover, is largely under-diagnosed. Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Child Malnutrition
How many people
102 participants
Where
1 siteFrance
Study dates
27 Feb 2023to 1 Jun 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 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: All children admitted for hospitalization or consultation during the study period until the required number of subjects was obtained. 300 subjects 150/150 : hospitalisation/consultation

Who may be able to join

  • Patient aged 6 months to less than 18 years
  • Patient admitted in short and long stay pediatric services at the Montpellier University Hospital, other than maternity, neonatality, palliative care or intensive care, excluding SSR.
  • Patient admitted for day hospitalization or consultation at the Montpellier University Hospital

Who cannot join

  • Opposition from parents or child
  • Pathology involving the satiety centers
  • Breast-fed child
  • Proven disorder of orality
  • Strict fasting by the medical team
  • Anorexia nervosa
  • Consciousness disorder
  • Exclusive artificial feeding

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34090

Other trials in France

About this study

In hospitalized children, undernutrition increases the length of hospitalization, aggravates the causal pathology, favors the occurrence of complications, and increases the cost of hospitalization. With a prevalence of 10 to 20%, undernutrition is therefore a major problem which, moreover, is largely under-diagnosed.

The evaluation of food intake has historically been based on the evaluation of food consumption by means of a food card or a food survey during the last 24 hours.

Read more

In adults, a rapid assessment tool has been developed, the SEFI® (Score Evaluation Facile des Ingestats), consisting of a visual analog scale (VAS) graduated from 0 to 10. It has been validated as being concordant with previous tools for the assessment of dietary intake in the general population and is now recommended for adults. It allows early identification of a risk of undernutrition when the score is < 7/10.

We propose to evaluate the correlation between this 10-point analog scale (SEFI) and ingesta in children in relation to recommended energy intakes for age and weight.

Read the detailed description

Data collection at the foot of the bed during hospitalization or after the consultation on a data collection form.

Conventional admission of patients to the departments involved. Carrying out the study (questionnaire and measurements) in the room. It will not be necessary to move the patients. The weighing and measuring of patients is not different from the usual care carried out during an admission to hospital in the services concerned by the study. All anthropometric measurements correspond to the recommendations of good practice. Anthropometric measurements will be performed by the health care team.

The dietary survey will be carried out by a dietician from the UTN or the pediatric team with an evaluation of the caloric intake at the time. The results will then be entered into the GENI software using the CIQUAL table in order to calculate the caloric intake (and the composition of trace elements and vitamins) according to standardized tables of food composition. The child will be accompanied by his or her parents for this survey.

The child will be asked the following question: "On a scale of 0 to 10, if 0 is "in terms of quantity, I don't eat anything at all" and 10 is "I eat as usual", between 0 and 10 where do you stand today? The same question will be asked of the parent. The parent will be blind to the child's response.

Blinding between the different assessments will be maintained as follows: the dietary survey will be conducted by a dietician blind to the SEFI scores, and the SEFI will be administered to the child and parents separately, by 2 different blind operators (childcare workers or assistant childcare workers), themselves blind to the dietary survey.

Keywords
children, undernutriton, food intake
Medical subject headings
Child Nutrition Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the diagnostic validity of the SEFI, a 10-item self-administered numerical scale assessing food intake, for the diagnosis of decreased ingesta in children.

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient. the thresholds that will be tested is <7/10.

    Reference test Ingesta representing at least 2/3 of recommended ingesta. Ingesta is assessed by a 24-hour recall performed by a dietician with children, accompanied by their parents.

    Measured: At the inclusion

  2. To assess the diagnostic validity of the SEFI, a 10-item self-administered numerical scale assessing food intake, for the diagnosis of decreased ingesta in children.

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient. the thresholds that will be tested is <10/10.

    Reference test Ingesta representing at least 2/3 of recommended ingesta. Ingesta is assessed by a 24-hour recall performed by a dietician with children, accompanied by their parents.

    Measured: At the inclusion

Secondary outcomes (5)

  1. Measure of percentage of ingesta against recommended ingesta

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient.

    Reference test: the percentage of caloric consumption in relation to the recommended ingesta according to age.

    Measured: At the inclusion

  2. Measure of undernutrition in children with the SEFI <7/10

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient. The thresholds that will be tested is <7/10.

    Reference test: Diagnosis of undernutrition according to the HAS 2019.

    Measured: At 4 months (end of the recruitment period)

  3. Measure of nutritional deficiencies in the diet

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient.

    Reference test: Nutrition deficeinies in the diet according to international recommendations for children's intakes

    Measured: At the inclusion

  4. Concordance of the SEFI administered to children and the SEFI administered to parents

    Concordance between a Probationary Test and a Reference Test:

    Probationary test

    Verbal assessment of ingesta by the SEFI, administered orally to the patient.

    Reference test: Verbal assessment of ingesta by the SEFI, administered orally to the parents.

    Measured: At the inclusion

  5. Number of children's responses to the SEFI according to age

    Measured: At the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start27 Feb 2023
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Why it stopped: Sufficient number of subjects included for analyzes

Resources

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
Cross-sectional
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726422
Sponsor's protocol ID
RECHMPL22_0308
Other IDs
2022-A01448-35
Acronym
CESAR
Status last verified
Aug 2023
First submitted
19 Jan 2023
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hankard R, Colomb V, Piloquet H, Bocquet A, Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Girardet JP, Goulet O, Rieu D, Simeoni U, Turck D, Vidailhet M. [Malnutrition screening in clinical practice]. Arch Pediatr. 2012 Oct;19(10):1110-7. doi: 10.1016/j.arcped.2012.07.024. Epub 2012 Sep 5. French.

    PubMed 22959889

  • Diagnostic de la dénutrition de l'enfant et de l'adulte [Internet]. Haute Autorité de Santé. [cited 2021 May 24]. Available from: https://www.has-sante.fr/jcms/p_3118872/fr/diagnostic-de-la-denutrition-de-l-enfant-et-de-l-adulte

  • Thibault R, Goujon N, Le Gallic E, Clairand R, Sebille V, Vibert J, Schneider SM, Darmaun D. Use of 10-point analogue scales to estimate dietary intake: a prospective study in patients nutritionally at-risk. Clin Nutr. 2009 Apr;28(2):134-40. doi: 10.1016/j.clnu.2009.01.003. Epub 2009 Feb 14.

    PubMed 19223093

  • Guerdoux-Ninot E, Flori N, Janiszewski C, Vaille A, de Forges H, Raynard B, Baracos VE, Thezenas S, Senesse P. Assessing dietary intake in accordance with guidelines: Useful correlations with an ingesta-Verbal/Visual Analogue Scale in medical oncology patients. Clin Nutr. 2019 Aug;38(4):1927-1935. doi: 10.1016/j.clnu.2018.06.974. Epub 2018 Jun 30.

    PubMed 30355527

  • De Longueville C, Robert M, Debande M, Podlubnai S, Defourny S, Namane SA, Pace A, Brans C, Cayrol E, Goyens P, De Laet C. Evaluation of nutritional care of hospitalized children in a tertiary pediatric hospital. Clin Nutr ESPEN. 2018 Jun;25:157-162. doi: 10.1016/j.clnesp.2018.02.008. Epub 2018 Mar 14.

    PubMed 29779812

Questions about this trial

What is this clinical trial studying?

An observational study of Child Malnutrition, run by University Hospital, Montpellier at 1 site 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 8 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: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Sufficient number of subjects included for analyzes). Results are not available in the source record.

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?

To assess the diagnostic validity of the SEFI, a 10-item self-administered numerical scale assessing food intake, for the diagnosis of decreased ingesta in children. (time frame: At the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726422, which also lists 5 linked publications.

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 6 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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