Malnutrition and Outcome in Hospitalized Children in Europe
| Tracking Information | |||||
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| First Received Date ICMJE | May 27, 2010 | ||||
| Last Updated Date | January 10, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Length of Hospital Stay [ Time Frame: 60 days ] [ Designated as safety issue: No ] Length of Hospital Stay will be compared between malnourished and non malnourished children. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01132742 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
infection as a complication during hospital stay [ Time Frame: 60 days ] [ Designated as safety issue: No ] frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use) |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Malnutrition and Outcome in Hospitalized Children in Europe | ||||
| Official Title ICMJE | Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project) | ||||
| Brief 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). 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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. |
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| Condition ICMJE | Malnutrition | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | hospitalised children | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2567 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Croatia, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Romania, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01132742 | ||||
| Other Study ID Numbers ICMJE | ESPEN | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Koletzko - Office, Ludwig-Maximilians - University of Munich | ||||
| Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ludwig-Maximilians - University of Munich | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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