- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Thessaloniki, 그리스
- Technological Education Institute
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Groningen, 네덜란드
- Beatrix Children's Hospital, University Medical Center Groningen
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Rotterdam, 네덜란드
- Sophia Children's Hospital, Erasmus University
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Copenhagen, 덴마크
- Rigshospitalet, Copenhagen University Hospital
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Bavaria
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Munich, Bavaria, 독일, 80337
- Dr. von Hauner Children's Hospital. Munich, Germany
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Cluj-Napoca, 루마니아
- Spitalul Clinic da Urgenta pentru Copii
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Oxford, 영국
- Oxford Children's Hospital
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Yorkhill Glasgow, 영국
- Royal Hospital for Sick Children
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Petah Tikvah, 이스라엘
- Schneider Children's Hospital
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Milano, 이탈리아
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano
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Zagreb, 크로아티아
- Children's Hospital Zagreb
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Warsaw, 폴란드
- The Children's Memorial Health Institute
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Warsaw, 폴란드
- Medical Univ. of Warsaw
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Lille, 프랑스
- Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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hospitalised children
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Length of Hospital Stay
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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infection as a complication during hospital stay
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Berthold Koletzko, Prof, Ludwig-Maximilians - University of Munich
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .