Malnutrition and Outcome in Hospitalized Children in Europe

NCT ID: NCT01132742

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hospitalised children

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Koletzko - Office

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Koletzko, Prof

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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Children's Hospital Zagreb

Zagreb, , Croatia

Site Status

Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

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

Lille, , France

Site Status

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

Munich, Bavaria, Germany

Site Status

Technological Education Institute

Thessaloniki, , Greece

Site Status

Schneider Children's Hospital

Petah Tikvah, , Israel

Site Status

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano

Milan, , Italy

Site Status

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, , Netherlands

Site Status

Sophia Children's Hospital, Erasmus University

Rotterdam, , Netherlands

Site Status

Medical Univ. of Warsaw

Warsaw, , Poland

Site Status

The Children's Memorial Health Institute

Warsaw, , Poland

Site Status

Spitalul Clinic da Urgenta pentru Copii

Cluj-Napoca, , Romania

Site Status

Oxford Children's Hospital

Oxford, , United Kingdom

Site Status

Royal Hospital for Sick Children

Yorkhill Glasgow, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 27099244 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24461472 (View on PubMed)

Other Identifiers

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ESPEN

Identifier Type: -

Identifier Source: org_study_id

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