MalnutritionNCT01132742
Malnutrition and Outcome in Hospitalized Children in Europe
An observational study of Malnutrition, run by Ludwig-Maximilians - University of Munich at 14 sites in 11 countries.
Trial summary
Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Malnutrition
- How many people
- 2,567 participants
- Where
- 14 sitesin 11 countries
- Study dates
- Feb 2010to Dec 2012
- 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: This study will be performed in hospitalized children attending general paediatric wards. The network comprises at least 13 teams from at least 11 countries. A total of 2700 patients will be recruited.
Who may be able to join
- Children admitted to the participating hospitals during the study period
- Age between 1 month and 18 years
- Expected hospital stay exceeding 24 hours
- Parents/caregivers, as well as those patients capable to comprehend, agree to participation and sign the informed consent form
Who cannot join
- Infants with premature birth (<37 weeks gestational age) during the first 12 months of life
- Infants < 1 month of age
- Patients ≥ 18 years of age
- Children in need of intensive care
- Children admitted to day-care (LOS < 24hours)
- Patients admitted for elective reasons with an expected hospital stay <24 hours
Trial locations and contacts
14 sites in 11 countries.
14 sites in 11 countries
Netherlands2 sites
Beatrix Children's Hospital, University Medical Center Groningen
Groningen
Sophia Children's Hospital, Erasmus University
Rotterdam
Poland2 sites
Medical Univ. of Warsaw
Warsaw
The Children's Memorial Health Institute
Warsaw
United Kingdom2 sites
Oxford Children's Hospital
Oxford
Royal Hospital for Sick Children
Yorkhill Glasgow
France1 site
Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
Lille
Germany1 site
Dr. von Hauner Children's Hospital. Munich, Germany
Munich, Bavaria, 80337
Italy1 site
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
Milan
About this study
Official title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)
Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed.
One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.
- Conditions
- Malnutrition
- Keywords
- Malnutrition, children, Hospital Stay, Screening Tools, Anthropometry
- 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 |
|---|---|---|
| hospitalised children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Length of Hospital Stay will be compared between malnourished and non malnourished children.
Measured: 60 days
Secondary outcomes (3)
infection as a complication during hospital stay
frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use)
Measured: 60 days
gastrointestinal complications (vomiting, diarrhoea)
frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay
Measured: 60 days
muscle strength
maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission
Measured: within 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- 2,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koletzko - Office, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132742
- Sponsor's protocol ID
- ESPEN
- Status last verified
- Jan 2013
- First submitted
- 27 May 2010
- Last updated
- 11 Jan 2013
- Results posted
- No
Publications
Chourdakis M, Hecht C, Gerasimidis K, Joosten KF, Karagiozoglou-Lampoudi T, Koetse HA, Ksiazyk J, Lazea C, Shamir R, Szajewska H, Koletzko B, Hulst JM. Malnutrition risk in hospitalized children: use of 3 screening tools in a large European population. Am J Clin Nutr. 2016 May;103(5):1301-10. doi: 10.3945/ajcn.115.110700. Epub 2016 Apr 20.
PubMed 27099244Hecht C, Weber M, Grote V, Daskalou E, Dell'Era L, Flynn D, Gerasimidis K, Gottrand F, Hartman C, Hulst J, Joosten K, Karagiozoglou-Lampoudi T, Koetse HA, Kolacek S, Ksiazyk J, Niseteo T, Olszewska K, Pavesi P, Piwowarczyk A, Rousseaux J, Shamir R, Sullivan PB, Szajewska H, Vernon-Roberts A, Koletzko B. Disease associated malnutrition correlates with length of hospital stay in children. Clin Nutr. 2015 Feb;34(1):53-9. doi: 10.1016/j.clnu.2014.01.003. Epub 2014 Jan 11.
PubMed 24461472
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)
- ClinicalTrials.gov ID
- NCT01132742
- Acronym / sponsor ID
- ESPEN
- Conditions
- Malnutrition
- Keywords
- Malnutrition, children, Hospital Stay, Screening Tools, Anthropometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,567 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 May 2010 (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.
Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed.
One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalised children | – | – |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will be performed in hospitalized children attending general paediatric wards. The network comprises at least 13 teams from at least 11 countries. A total of 2700 patients will be recruited.
Key inclusion criteria (4 listed)
- Children admitted to the participating hospitals during the study period
- Age between 1 month and 18 years
- Expected hospital stay exceeding 24 hours
- Parents/caregivers, as well as those patients capable to comprehend, agree to participation and sign the informed consent form
Key exclusion criteria (6 listed)
- Infants with premature birth (<37 weeks gestational age) during the first 12 months of life
- Infants < 1 month of age
- Patients ≥ 18 years of age
- Children in need of intensive care
- Children admitted to day-care (LOS < 24hours)
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
Length of Hospital Stay
Time frame: 60 days
Length of Hospital Stay will be compared between malnourished and non malnourished children.
3 secondary outcomes
infection as a complication during hospital stay
Time frame: 60 days
gastrointestinal complications (vomiting, diarrhoea)
Time frame: 60 days
muscle strength
Time frame: within 24 hours after admission
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 11 Jan 2013.
- Derived from this study: PubMed 27099244Chourdakis M, Hecht C, Gerasimidis K, Joosten KF, Karagiozoglou-Lampoudi T, Koetse HA, Ksiazyk J, Lazea C, Shamir R, Szajewska H, Koletzko B, Hulst JM. Malnutrition risk in hospitalized children: use of 3 screening tools in a large European population. Am J Clin Nutr. 2016 May;103(5):1301-10. doi: 10.3945/ajcn.115.110700. Epub 2016 Apr 20.
- Derived from this study: PubMed 24461472Hecht C, Weber M, Grote V, Daskalou E, Dell'Era L, Flynn D, Gerasimidis K, Gottrand F, Hartman C, Hulst J, Joosten K, Karagiozoglou-Lampoudi T, Koetse HA, Kolacek S, Ksiazyk J, Niseteo T, Olszewska K, Pavesi P, Piwowarczyk A, Rousseaux J, Shamir R, Sullivan PB, Szajewska H, Vernon-Roberts A, Koletzko B. Disease associated malnutrition correlates with length of hospital stay in children. Clin Nutr. 2015 Feb;34(1):53-9. doi: 10.1016/j.clnu.2014.01.003. Epub 2014 Jan 11.
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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.
Berthold Koletzko, Prof principal investigator
Ludwig-Maximilians - University of Munich
14 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Ludwig-Maximilians - University of Munich at 14 sites in 11 countries.
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 4 inclusion and 6 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 11 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands, Poland, United Kingdom, Croatia, Denmark and 6 more countries. 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?
Length of Hospital Stay (time frame: 60 days). 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 NCT01132742, which also lists 2 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 11 Jan 2013.