- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01132742
Malnutrition and Outcome in Hospitalized Children in Europe
Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bavaria
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Munich, Bavaria, Alemania, 80337
- Dr. von Hauner Children's Hospital. Munich, Germany
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Zagreb, Croacia
- Children's Hospital Zagreb
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Copenhagen, Dinamarca
- Rigshospitalet, Copenhagen University Hospital
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Lille, Francia
- Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
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Thessaloniki, Grecia
- Technological Education Institute
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Petah Tikvah, Israel
- Schneider Children's Hospital
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Milano, Italia
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
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Groningen, Países Bajos
- Beatrix Children's Hospital, University Medical Center Groningen
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Rotterdam, Países Bajos
- Sophia Children's Hospital, Erasmus University
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Warsaw, Polonia
- The Children's Memorial Health Institute
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Warsaw, Polonia
- Medical Univ. of Warsaw
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Oxford, Reino Unido
- Oxford Children's Hospital
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Yorkhill Glasgow, Reino Unido
- Royal Hospital for Sick Children
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Cluj-Napoca, Rumania
- Spitalul Clinic da Urgenta pentru Copii
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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hospitalised children
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Length of Hospital Stay
Periodo de tiempo: 60 days
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Length of Hospital Stay will be compared between malnourished and non malnourished children.
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60 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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infection as a complication during hospital stay
Periodo de tiempo: 60 days
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frequency of infectious complications (number of days with temperature >38,5°C, number of days with days with antibiotic use)
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60 days
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gastrointestinal complications (vomiting, diarrhoea)
Periodo de tiempo: 60 days
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frequency of gastrointestinal complications: frequency of vomiting and diarrhoea during hospital stay
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60 days
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muscle strength
Periodo de tiempo: within 24 hours after admission
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maximal isometric grip force in children ≥ 6 years of age measured within 24 hours after admission
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within 24 hours after admission
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Berthold Koletzko, Prof, Ludwig-Maximilians - University of Munich
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ESPEN
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