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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
  Purpose

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
Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 2567
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
hospitalised children

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132742

Locations
Croatia
Children's Hospital Zagreb
Zagreb, Croatia
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
France
Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
Lille, France
Germany
Dr. von Hauner Children's Hospital. Munich, Germany
Munich, Bavaria, Germany, 80337
Greece
Technological Education Institute
Thessaloniki, Greece
Israel
Schneider Children's Hospital
Petah Tikvah, Israel
Italy
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
Milano, Italy
Netherlands
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands
Sophia Children's Hospital, Erasmus University
Rotterdam, Netherlands
Poland
Medical Univ. of Warsaw
Warsaw, Poland
The Children's Memorial Health Institute
Warsaw, Poland
Romania
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
Investigators
Principal Investigator: Berthold Koletzko, Prof Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Koletzko - Office, Prof, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01132742     History of Changes
Other Study ID Numbers: ESPEN
Study First Received: May 27, 2010
Last Updated: January 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Malnutrition
children
Hospital Stay
Screening Tools
Anthropometry

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 27, 2014