NCT05726422

Brief 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. 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 6, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

January 19, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

childrenundernutritonfood intake

Outcome Measures

Primary Outcomes (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 \<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.

    At the inclusion

  • 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.

    At the inclusion

Secondary Outcomes (5)

  • Measure of percentage of ingesta against recommended ingesta

    At the inclusion

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

    At 4 months (end of the recruitment period)

  • Measure of nutritional deficiencies in the diet

    At the inclusion

  • Concordance of the SEFI administered to children and the SEFI administered to parents

    At the inclusion

  • Number of children's responses to the SEFI according to age

    At the inclusion

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier - Hôpital Lapeyronie

Montpellier, 34090, France

Location

Related Publications (5)

  • 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.

    PMID: 22959889BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 19223093BACKGROUND
  • 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.

    PMID: 30355527BACKGROUND
  • 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.

    PMID: 29779812BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 14, 2023

Study Start

February 27, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

October 6, 2023

Record last verified: 2023-08

Locations