Clinical trial NCT01132742: Malnutrition and Outcome in Hospitalized Children in Europe
Official title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Malnutrition
children
Hospital Stay
Screening Tools
Anthropometry
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 2567
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 60 days
Secondary outcomes:
measure: infection as a complication during hospital stay
timeFrame: 60 days
measure: gastrointestinal complications (vomiting, diarrhoea)
timeFrame: 60 days
measure: muscle strength
timeFrame: within 24 hours after admission
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
city: Lille
country: France
facility: Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
city: Munich
country: Germany
facility: Dr. von Hauner Children's Hospital. Munich, Germany
state: Bavaria
city: Thessaloniki
country: Greece
facility: Technological Education Institute
city: Petah Tikvah
country: Israel
facility: Schneider Children's Hospital
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
city: Groningen
country: Netherlands
facility: Beatrix Children's Hospital, University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Sophia Children's Hospital, Erasmus University
city: Warsaw
country: Poland
facility: Medical Univ. of Warsaw
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic da Urgenta pentru Copii
city: Oxford
country: United Kingdom
facility: Oxford Children's Hospital
city: Yorkhill Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Berthold Koletzko, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.