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Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes

  • Jarrold, Katharine1
  • Helfer, Bartosz1
  • Eskander, Mona2
  • Crawley, Helen3, 4
  • Trabulsi, Jillian5
  • Caulfield, Laura E.6
  • Duffy, Gillian7
  • Garcia-Larsen, Vanessa6
  • Hayward, Deborah2
  • Hyde, Matthew8
  • Jeffries, Suzan1, 9
  • Knip, Mikael10, 11
  • Leonardi-Bee, Jo12
  • Loder, Elizabeth13, 14
  • Lodge, Caroline J.15
  • Lowe, Adrian J.15
  • McGuire, William16
  • Osborn, David17
  • Przyrembel, Hildegard18
  • Renfrew, Mary J.19
  • And 4 more
  • 1 National Heart and Lung Institute, Imperial College London, London, United Kingdom
  • 2 Bureau of Nutritional Sciences, Food Directorate, Health Canada, Ottawa, Ontario, Canada
  • 3 First Steps Nutrition Trust, London, United Kingdom
  • 4 Scientific and Technical Advisory Group on the Inappropriate Promotion of Foods for Infants and Young Children, World Health Organization, Geneva, Switzerland
  • 5 Department of Behavioral Health and Nutrition, University of Delaware, Newark
  • 6 Center for Human Nutrition, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 7 Department of Public Health Nutrition Standards, Food Standards Australia New Zealand, Canberra, Australia
  • 8 Section of Neonatal Medicine, Imperial College London, London, United Kingdom
  • 9 International Board of Certified Lactation Consultant Examiners, Fairfax, Virginia
  • 10 Children’s Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
  • 11 Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland
  • 12 Medical Statistics, University of Nottingham, Nottingham, United Kingdom
  • 13 , London, United Kingdom
  • 14 Department of Neurology, Harvard Medical School, Cambridge, Massachusetts
  • 15 Allergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  • 16 Centre for Reviews and Dissemination, University of York, York, United Kingdom
  • 17 Division of Obstetrics, Gynaecology and Neonatology, University of Sydney, Sydney, New South Wales, Australia
  • 18 Department of Food Safety, Federal Institute for Risk Assessment, Berlin, Germany
  • 19 Mother and Infant Research Unit, University of Dundee School of Nursing and Health Sciences, Dundee, United Kingdom
  • 20 Nutrition Programs, Food and Drug Administration, Silver Spring, Maryland
  • 21 Department of Nutrition, University of California, Davis, Davis
  • 22 Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, United Kingdom
Published Article
JAMA Pediatrics
American Medical Association
Publication Date
May 11, 2020
DOI: 10.1001/jamapediatrics.2020.0578
PMID: 32391870
PMCID: PMC7215627
PubMed Central
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This consensus guidance summarizes best practice for the design, conduct, analysis, and reporting of trials of breast milk substitutes.

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