MalnutritionNUTRI-REAPEDNCT02293434
Nutritional Status on Admission to Pediatric Intensive Care
An observational study of Malnutrition and Dwarf - Nutritional, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs. As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Malnutrition, Dwarf - Nutritional
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2014
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children (1 month to 18 years) admitted to all PICUs in France
Who may be able to join
- All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.
As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.
Read more
Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.
Secondary objectives:
- Determine the children's nutritional status on admission.
- Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
- Describe the practices regarding nutritional care in each center.
Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
Read the detailed description
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.
As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.
Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.
Secondary objectives:
- Determine the children's nutritional status on admission.
- Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
- Describe the practices regarding nutritional care in each center.
Study design:
- Type of study: Observational, descriptive, transversal, and multicentric.
- Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
- Primary assessment parameter: Malnutrition, as defined by the body mass index (BMI) value <-2 SD, according to the WHO Child Growth Standards.
- Factors studied:
- Nutritional status on admission based on the measurement of simple anthropometric parameters: weight (W), height (H), head circumference (HC) and mid-upper arm circumference (MUAC), which are then used to calculate malnutrition indices.
- Profile of malnourished patients in relation to hospitalization parameters (age, sex, reason for admission, history, dietary habits).
- Nutritional practices in PICUs assessed with two questionnaires (medical and nursing) sent to all participating hospitals.
- Sample size: Number of subjects needed to estimate the prevalence of malnutrition, based on the data in the literature with a confidence interval of 95%±3.2%: 600.
- Conditions
- Malnutrition, Dwarf - Nutritional
- Keywords
- Malnutrition, Status Nutritional Weight, Pediatric intensive care
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Children (1 month to 18 years) | All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Nutritional status (measurement of simple anthropometric parameters, which are then used to calculate malnutrition indices) on admission
Measured: Baseline
Secondary outcomes (1)
Nutritional practice in PICUs
Nutritional practice in PICUs once during the study : two questionnaires (medical and nursing) sent to all participating hospitals
Measured: 1 day ( once during the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien JACQUOT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293434
- Sponsor's protocol ID
- 9251
- Acronym
- NUTRI-REAPED
- Status last verified
- Nov 2014
- First submitted
- 11 Aug 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study
- ClinicalTrials.gov ID
- NCT02293434
- Acronym / sponsor ID
- NUTRI-REAPED / 9251
- Conditions
- Malnutrition, Dwarf - Nutritional
- Keywords
- Malnutrition, Status Nutritional Weight, Pediatric intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Nov 2014 (estimated)
- 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.
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.
As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.
Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.
Secondary objectives:
- Determine the children's nutritional status on admission.
- Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
- Describe the practices regarding nutritional care in each center.
Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
Detailed description
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.
As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.
Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.
Secondary objectives:
- Determine the children's nutritional status on admission.
- Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
- Describe the practices regarding nutritional care in each center.
Study design:
- Type of study: Observational, descriptive, transversal, and multicentric.
- Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
- Primary assessment parameter: Malnutrition, as defined by the body mass index (BMI) value <-2 SD, according to the WHO Child Growth Standards.
- Factors studied:
- Nutritional status on admission based on the measurement of simple anthropometric parameters: weight (W), height (H), head circumference (HC) and mid-upper arm circumference (MUAC), which are then used to calculate malnutrition indices.
- Profile of malnourished patients in relation to hospitalization parameters (age, sex, reason for admission, history, dietary habits).
- Nutritional practices in PICUs assessed with two questionnaires (medical and nursing) sent to all participating hospitals.
- Sample size: Number of subjects needed to estimate the prevalence of malnutrition, based on the data in the literature with a confidence interval of 95%±3.2%: 600.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Children (1 month to 18 years) | – | –All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children (1 month to 18 years) admitted to all PICUs in France
Key inclusion criteria (1 listed)
- All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.
Key exclusion criteria (0 listed)
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
Nutritional status
Time frame: Baseline
Nutritional status (measurement of simple anthropometric parameters, which are then used to calculate malnutrition indices) on admission
1 secondary outcome
Nutritional practice in PICUs
Time frame: 1 day ( once during the study)
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 20 Nov 2015.
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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.
Aurélien JACQUOT, MD principal investigator
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 Malnutrition and Dwarf - Nutritional, 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 1 inclusion and 0 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 20 Nov 2015. 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?
Nutritional status (time frame: Baseline). 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 20 Nov 2015.