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Malnutrition and Outcome in Hospitalized Children in Europe

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01132742
First received: May 27, 2010
Last updated: January 10, 2013
Last verified: January 2013

May 27, 2010
January 10, 2013
February 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01132742 on ClinicalTrials.gov Archive Site
  • 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)
  • gastrointestinal complications (vomiting, diarrhoea) [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay
  • muscle strength [ Time Frame: within 24 hours after admission ] [ Designated as safety issue: No ]
    maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission
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)
Not Provided
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Malnutrition and Outcome in Hospitalized Children in Europe
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Malnutrition
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hospitalised children
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2567
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Netherlands,   Poland,   Romania,   United Kingdom
 
NCT01132742
ESPEN
Not Provided
Koletzko - Office, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Berthold Koletzko, Prof Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP