Malnutrition and Outcome in Hospitalized Children in Europe

Malnutrition Clinical Trial

Official title:

Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132742
• Other study ID #: ESPEN
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: January 10, 2013
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2567
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Countries where clinical trial is conducted

Croatia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	Length of Hospital Stay will be compared between malnourished and non malnourished children.	60 days	No
Secondary	infection as a complication during hospital stay	frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use)	60 days	No
Secondary	gastrointestinal complications (vomiting, diarrhoea)	frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay	60 days	No
Secondary	muscle strength	maximal isometric grip force in children = 6 years of age measured within 24 hours after admission	within 24 hours after admission	No