Malnutrition and Outcome in Hospitalized Children in Europe

Completed

• Conditions: Malnutrition

• Registration Number: NCT01132742
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2567

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	60 days	Length of Hospital Stay will be compared between malnourished and non malnourished children.

Secondary Outcome Measures

Name	Time	Method
muscle strength	within 24 hours after admission	maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission
infection as a complication during hospital stay	60 days	frequency of infectious complications (number of days with temperature \>38,5°C, number of days with days with antibiotic use)
gastrointestinal complications (vomiting, diarrhoea)	60 days	frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay

Trial Locations

Locations (14)

Beatrix Children's Hospital, University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Sophia Children's Hospital, Erasmus University; 🇳🇱 Rotterdam, Netherlands

Medical Univ. of Warsaw; 🇵🇱 Warsaw, Poland

Schneider Children's Hospital; 🇮🇱 Petah Tikvah, Israel

The Children's Memorial Health Institute; 🇵🇱 Warsaw, Poland

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

Children's Hospital Zagreb; 🇭🇷 Zagreb, Croatia

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

Technological Education Institute; 🇬🇷 Thessaloniki, Greece

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano; 🇮🇹 Milano, Italy

Spitalul Clinic da Urgenta pentru Copii; 🇷🇴 Cluj-Napoca, Romania

Oxford Children's Hospital; 🇬🇧 Oxford, United Kingdom

Royal Hospital for Sick Children; 🇬🇧 Yorkhill Glasgow, United Kingdom