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NCT Number: NCT01132742

Malnutrition and Outcome in Hospitalized Children in Europe

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Zagreb, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Length of Hospital Stay

    Time frame: 60 days

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

Secondary outcomes

  1. infection as a complication during hospital stay

    Time frame: 60 days

    frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use)

  2. gastrointestinal complications (vomiting, diarrhoea)

    Time frame: 60 days

    frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay

  3. muscle strength

    Time frame: within 24 hours after admission

    maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 28, 2010
Registry last updated
Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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