Malnutrition and Outcome in Hospitalized Children in Europe

NCT01132742 | Completed

• 1 other identifier: ESPEN
• Study Type: observational
• Target: 2,567
• Locations: 11 countries
• Sites: 14

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.

Conditions

Malnutrition

Keywords

Malnutrition; children; Hospital Stay; Screening Tools; Anthropometry

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  Length of Hospital Stay will be compared between malnourished and non malnourished children.

  60 days

Secondary Outcomes (3)

• infection as a complication during hospital stay

  60 days

• gastrointestinal complications (vomiting, diarrhoea)

  60 days

• muscle strength

  within 24 hours after admission

Study Arms (1)

hospitalised children

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (14)

Children's Hospital Zagreb

Zagreb, Croatia

Location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.

Lille, France

Location

Dr. von Hauner Children's Hospital. Munich, Germany

Munich, Bavaria, 80337, Germany

Location

Technological Education Institute

Thessaloniki, Greece

Location

Schneider Children's Hospital

Petah Tikvah, Israel

Location

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano

Milan, Italy

Location

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, Netherlands

Location

Sophia Children's Hospital, Erasmus University

Rotterdam, Netherlands

Location

Medical Univ. of Warsaw

Warsaw, Poland

Location

The Children's Memorial Health Institute

Warsaw, Poland

Location

Spitalul Clinic da Urgenta pentru Copii

Cluj-Napoca, Romania

Location

Oxford Children's Hospital

Oxford, United Kingdom

Location

Royal Hospital for Sick Children

Yorkhill Glasgow, United Kingdom

Location

Related Publications (2)

• Chourdakis M, Hecht C, Gerasimidis K, Joosten KF, Karagiozoglou-Lampoudi T, Koetse HA, Ksiazyk J, Lazea C, Shamir R, Szajewska H, Koletzko B, Hulst JM. Malnutrition risk in hospitalized children: use of 3 screening tools in a large European population. Am J Clin Nutr. 2016 May;103(5):1301-10. doi: 10.3945/ajcn.115.110700. Epub 2016 Apr 20.

  PMID: 27099244 DERIVED

• Hecht C, Weber M, Grote V, Daskalou E, Dell'Era L, Flynn D, Gerasimidis K, Gottrand F, Hartman C, Hulst J, Joosten K, Karagiozoglou-Lampoudi T, Koetse HA, Kolacek S, Ksiazyk J, Niseteo T, Olszewska K, Pavesi P, Piwowarczyk A, Rousseaux J, Shamir R, Sullivan PB, Szajewska H, Vernon-Roberts A, Koletzko B. Disease associated malnutrition correlates with length of hospital stay in children. Clin Nutr. 2015 Feb;34(1):53-9. doi: 10.1016/j.clnu.2014.01.003. Epub 2014 Jan 11.

  PMID: 24461472 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Berthold Koletzko, Prof

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

IT (1); IL (1); NL (2); PL (2); DK (1); FR (1); CR (1); DE (1); GR (1); RO (1); GB (2)