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. 2020 Sep 1;174(9):874-881.
doi: 10.1001/jamapediatrics.2020.0578.

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

Katharine Jarrold  1 , Bartosz Helfer  1 , Mona Eskander  2 , Helen Crawley  3   4 , Jillian Trabulsi  5 , Laura E Caulfield  6 , Gillian Duffy  7 , Vanessa Garcia-Larsen  6 , Deborah Hayward  2 , Matthew Hyde  8 , Suzan Jeffries  1   9 , Mikael Knip  10   11 , Jo Leonardi-Bee  12 , Elizabeth Loder  13   14 , Caroline J Lodge  15 , Adrian J Lowe  15 , William McGuire  16 , David Osborn  17 , Hildegard Przyrembel  18 , Mary J Renfrew  19 , Paula Trumbo  20 , John Warner  1 , Barbara Schneeman  21 , Robert J Boyle  1   22
Affiliations

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

Katharine Jarrold et al. JAMA Pediatr. .

Abstract

Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials.

Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products.

Design, setting, and participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee.

Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures.

Conclusions and relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Helfer reported that his employing institution, Imperial College London, has a formal research and innovation partnership with Nestlé; Dr Helfer is not directly involved in this partnership. Dr Trabulsi reported receiving personal fees from Paidion Clinical Research and ByHeart Inc outside the submitted work. Ms Hayward reported being Head of Infant Nutrition for Health Canada, Government of Canada, and responsible for the analysis of clinical growth and tolerance data for the premarket notification of infant formulas in Canada; the Government of Canada supports breastfeeding when possible, and Ms Hayward reported taking part in work on human milk composition with the US Government. Dr Hyde reported having spoken for the UNICEF UK Baby Friendly Hospital Initiative and working in a research group in receipt of research funding from Nestlé, Danone, and Prolacta. Ms Jeffries reported working in a research group that has received research funding from Nestlé, Danone, and Prolacta; receiving funding from Nestlé to attend a conference; and beng previously employed as a research midwife for a breast milk substitute study funded by Nutricia. Dr Leonardi-Bee reported receiving personal fees from Dairy Goat Co-operative, Danone Nutricia Research, and UK Food Standards Agency outside the submitted work. Dr Lowe reported receiving grants from National Health and Medical Research Council, Australia; and nonfinancial support from PuraCap Pharmaceuticals outside the submitted work. Dr McGuire reported receiving grants from the National Institute for Health Research (UK) outside the submitted work. Dr Warner reported receiving grants and personal fees from Danone/Nutricia and Airsonett; personal fees from Anaphylaxis Campaign and Friesland Campina; and grants from the National Institute for Health Research (UK) outside the submitted work. Dr Boyle reported receiving nonfinancial support from the National Institute for Health Research during the conduct of the study; personal fees from Dairy Goat Co-operative, Prota Therapeutics, DBV Technologies, Cochrane, Squiteri and Fearon, Taus, Cebulash and Landau, and ALK Abelo outside the submitted work; and Dr Boyle’s employing institution, Imperial College London, has a formal research and innovation partnership with Nestlé, who manufacture and market infant formula products and sponsor infant formula research; Dr Boyle is not directly involved in this research and innovation partnership and does not undertake research work with Nestlé. No other disclosures were reported.

Figures

Figure.
Figure.. Summary of Delphi Consensus Process
A summary of the actions taken during each step of the Delphi consensus process is shown. BMS indicates breast milk substitute.
See this image and copyright information in PMC

References

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