UndernutritionEDENNCT04482218
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations
An observational study of Undernutrition, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%. Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Undernutrition
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 30 Sep 2020
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 admitted for hospitalization in the pediatric deparment of the Montpellier University Hospital
Who may be able to join
- Patient under 18 years old (HAS 2019)
- Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.
Who cannot join
- Parental or child opposition
- Legal guardian unable to express consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.
Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.
Read more
Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.
The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.
The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.
Read the detailed description
The investigators will conduct a prospective cohort without change in care.
Following classic patient admission in involved departments, the investigating team moves to the department to collect data.
The measurements and informations collected are no different from those taken in the context of normal care.
All anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.
With collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.
For any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.
Data collected are as follows:
Simple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.
Assessment of ingesta. A non-opposition will be asked
- Conditions
- Undernutrition
- Keywords
- Nutrition, Antromopemtric data, Pediatry
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
Measured: 2 month
Secondary outcomes (1)
Identified profiles of children who do match between the two diagnostics methods
Identified profiles of children who do match between the two diagnostics methods
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start17 Jul 2020
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine AVIGNON, PR, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482218
- Sponsor's protocol ID
- RECHMPL20_0391
- Acronym
- EDEN
- Status last verified
- Dec 2020
- First submitted
- 17 Jul 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations
- ClinicalTrials.gov ID
- NCT04482218
- Acronym / sponsor ID
- EDEN / RECHMPL20_0391
- Conditions
- Undernutrition
- Keywords
- Nutrition, Antromopemtric data, Pediatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 Jul 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.
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.
Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.
Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.
The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.
The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.
Detailed description
The investigators will conduct a prospective cohort without change in care.
Following classic patient admission in involved departments, the investigating team moves to the department to collect data.
The measurements and informations collected are no different from those taken in the context of normal care.
All anthropometric measurements correspond to recommendations of good practice. Anthropometric measurements will be carried out by the healthcare team.
With collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods.
For any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally.
Data collected are as follows:
Simple demographic characteristics: Age, sex, departmentsand principal diagnosis Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date of term of pregnancy. Clinical history: all pathologies or clinical events that may be related to a weight variation.
Assessment of ingesta. A non-opposition will be asked
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 admitted for hospitalization in the pediatric deparment of the Montpellier University Hospital
Key inclusion criteria (2 listed)
- Patient under 18 years old (HAS 2019)
- Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.
Key exclusion criteria (2 listed)
- Parental or child opposition
- Legal guardian unable to express consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
Time frame: 2 month
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
1 secondary outcome
Identified profiles of children who do match between the two diagnostics methods
Time frame: 2 month
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 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Antoine AVIGNON, PR study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernutrition, 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 2 inclusion and 2 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 29 Dec 2020. 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 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?
Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology (time frame: 2 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 29 Dec 2020.