Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENTKoletzko B.a · Szajewska H.b · Ashwell M.c · Shamir R.d · Aggett P.e · Baerlocher K.f · Noakes P.g · Braegger C.h · Calder P.g · Campoy Folgoso C.i · Colomb V.j · Decsi T.k · Domellöf M.l · Dupont C.j · Fewtrell M.m · van Goudoever J.B.n · Michaelsen K.F.o · Mihatsch W.p · Guarino A.q · Koletzko S.a · Rigo J.r · Turck D.s · Taminiau J.n · on behalf of the Early Nutrition Academy and European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition – Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials
aDr. von Hauner Children’s Hospital, University of Munich Medical Centre, Munich, Germany; bThe Medical University of Warsaw, Warsaw, Poland; cAshwell Associates (Europe) Ltd., Ashwell, UK; dSchneider Children’s Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; eSchool of Medicine and Health, Lancaster University, Lancaster, UK; fOstschweizerisches Kinderspital, St. Gallen, Switzerland; gSchool of Medicine, University of Southampton, Southampton, UK; hKinderspital, University of Zurich, Zurich, Switzerland; iDepartment of Paediatrics, University of Granada, Granada, Spain; jHôpital Necker – Enfants Malades, Paris, France; kDepartment of Paediatrics, University of Pecs, Pecs, Hungary; lDepartment of Paediatrics, University of Umea, Umea, Sweden; mInstitute of Child Health, University College London, London, UK; nDepartment of Paediatrics, Emma Children’s Hospital – Academic Medical Centre and VU University Medical Centre Amsterdam, Amsterdam, The Netherlands; oInstitute of Human Nutrition, University of Copenhagen, Copenhagen, Denmark; pEvangelisches Diakoniekrankenhaus, Schwäbisch Hall, Germany; qDepartment of Paediatrics, University of Naples, Naples, Italy; rDepartment of Paediatrics, University of Liege, Liege, Belgium; sJeanne de Flandre Children’s Hospital, University of Lille, Lille, France
Keywords: Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical TrialsEuropean Society for Paediatric Gastroenterology, Hepatology and NutritionEarly Nutrition AcademyFunctional effectsNutritional interventionsInfantsYoung childrenClinical trialsMarkersOutcome measuresAllergyGrowthDiarrhoeaCore data
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The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional interventions in infants and young children. The four objectives were to (1) provide guidance on the quality and quantity of evidence needed to justify conclusions on functional and clinical effects of nutrition in infants and young children aged <3 years; (2) agree on a range of outcome measures relevant to nutrition trials in this age group for which agreed criteria are needed; (3) agree on an updated ‘core data set’ that should generally be recorded in nutrition trials in infants and young children, and (4) provide guidance on the use of surrogate markers in paediatric nutrition research. The participants discussed these objectives and agreed to set up six first working groups under the auspices of the Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT). Five groups will aim to identify and define criteria for assessing key outcomes, i.e. growth, acute diarrhoea, atopic dermatitis and cows’ milk protein allergy, infections and ‘gut comfort’. The sixth group will review and update the ‘core data set’. The COMMENT Steering Committee will discuss and decide upon a method for reaching consensus which will be used by all working groups and plan to meet again within 2 years and to report and publish their conclusions.
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