Malnutrition and Outcome in Hospitalized Children in Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132742
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : January 11, 2013
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 2567 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)
Study Start Date : February 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

hospitalised children

Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: 60 days ]
    Length of Hospital Stay will be compared between malnourished and non malnourished children.

Secondary Outcome Measures :
  1. infection as a complication during hospital stay [ Time Frame: 60 days ]
    frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use)

  2. gastrointestinal complications (vomiting, diarrhoea) [ Time Frame: 60 days ]
    frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay

  3. muscle strength [ Time Frame: within 24 hours after admission ]
    maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132742

Children's Hospital Zagreb
Zagreb, Croatia
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
Lille, France
Dr. von Hauner Children's Hospital. Munich, Germany
Munich, Bavaria, Germany, 80337
Technological Education Institute
Thessaloniki, Greece
Schneider Children's Hospital
Petah Tikvah, Israel
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
Milano, Italy
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands
Sophia Children's Hospital, Erasmus University
Rotterdam, Netherlands
Medical Univ. of Warsaw
Warsaw, Poland
The Children's Memorial Health Institute
Warsaw, Poland
Spitalul Clinic da Urgenta pentru Copii
Cluj-Napoca, Romania
United Kingdom
Oxford Children's Hospital
Oxford, United Kingdom
Royal Hospital for Sick Children
Yorkhill Glasgow, United Kingdom
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Principal Investigator: Berthold Koletzko, Prof Ludwig-Maximilians - University of Munich