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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06026059
Other study ID # RC31/20/0059
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 6, 2020
Est. completion date October 6, 2022

Study information

Verified date August 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings,however, in some cases, these tools cannot be used due to lack of data. That's why a tool that doesn't require any anthropometric parameters, such as a visual food intake scale, could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.


Description:

HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative energy and/or protein balance. This negative balance may be linked to a deficit in isolated intake and/or an increase in energy and/or protein expenditure. In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings. Practitioners can use discs to quickly and easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However, in some cases, these tools cannot be used due to lack of data. That's why a tool that doesn't require any anthropometric parameters could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening. In adults, a visual food intake scale exists and has been validated for screening for nutritional risk. The hypothesis of this study is that the visual food intake scale could be a good tool for screening for nutritional risk in paediatrics


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 6, 2022
Est. primary completion date October 6, 2022
Accepts healthy volunteers No
Gender All
Age group 8 Years to 15 Years
Eligibility Inclusion Criteria: - Child able to be weighed and measured - Family with Internet access and telephone number - Child and at least one parent present during day hospitalization, - Child able to respond to the SEFI® scale and having completed the 3-day food intake at home Exclusion Criteria: - Children and/or parents with comprehension and/or communication difficulties - Children with any pathological condition making interpretation of results difficult from the investigator's point of view - Children receiving nutritional support: enteral and parenteral nutrition. - Child with nutritional follow-up

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the SEFI scale as a screening tool for child's nutritional risk. The correlation between the self evaluation of food intake (SEFI) scale, with scores from 0 to 10, indicating the presence of malnutrition score if score is inferior to 7 or absence of malnutrition if score superior to 7/10, and the STRONGkids score will be evaluated Day 1
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