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Documentation of functional and clinical effects of infant nutrition: setting the scene for COMMENT
Berthold Koletzko1, Hania Szajewska, Margaret Ashwell
1Dr. von Hauner Children's Hospital, University of Munich Medical Centre, Germany. office.koletzko@med.uni-muenchen.de
Insights
Establishing evidence-based guidelines for pediatric nutrition trials is crucial. The Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT) aims to define outcome measures and core data sets for infants and young children.
Area of Science:
- Pediatric Nutrition
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- A 2011 workshop convened by the Early Nutrition Academy and Child Health Foundation addressed evidence acquisition for nutritional interventions in young children.
- Collaboration involved the European Society for Paediatric Gastroenterology, Hepatology and Nutrition's Committee on Nutrition.
Purpose of the Study:
- To provide guidance on evidence quality and quantity for nutritional effects in children under 3 years.
- To establish agreed outcome measures and criteria for pediatric nutrition trials.
- To update the core data set for infant and young child nutrition studies.
- To offer guidance on using surrogate markers in pediatric nutrition research.
Main Methods:
- Formation of the Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT).
- Establishment of six working groups to define criteria for key outcomes (growth, diarrhea, allergy, infections, gut comfort) and update the core data set.
- Development of a consensus methodology for all working groups.
Main Results:
- Agreement to establish working groups under the COMMENT initiative.
- Focus on defining criteria for growth, acute diarrhea, atopic dermatitis, cow's milk protein allergy, infections, and gut comfort.
- Commitment to review and update the core data set for nutrition trials.
Conclusions:
- The COMMENT group will define standardized outcome measures and data collection for pediatric nutrition research.
- Future meetings are planned within two years to report and publish consensus findings.
- This initiative aims to improve the quality and comparability of evidence from pediatric nutrition trials.
Abstract:
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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