Malnutrition and Outcome in Hospitalized Children in Europe

January 10, 2013 updated by: Koletzko - Office, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2567

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
hospitalised children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: 60 days
Length of Hospital Stay will be compared between malnourished and non malnourished children.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
60 days
gastrointestinal complications (vomiting, diarrhoea)
Time Frame: 60 days
frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay
60 days
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
within 24 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Berthold Koletzko, Prof, Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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