Skip to main content

Research Repository

Advanced Search

Guidance for the Conduct and Reporting of Clinical Trials of Breastmilk Substitutes: a Delphi Consensus Statement

Jarrold, Katharine; Helfer, Bartosz; Eskander, Mona; Crawley, Helen; Trabulsi, Jillian; Caulfield, Laura E.; Duffy, Gillian; Garcia-Larsen, Vanessa; Hayward, Deborah; Hyde, Matthew; Jeffries, Suzan; Knip, Mikael; Leonardi-Bee, Jo; Loder, Elizabeth; Lodge, Caroline J.; Lowe, Adrian J.; McGuire, William; Osborn, David; Przyrembel, Hildegard; Renfrew, Mary J.; Trumbo, Paula; Warner, John; Schneeman, Barbara; Boyle, Robert J.


Katharine Jarrold

Bartosz Helfer

Mona Eskander

Helen Crawley

Jillian Trabulsi

Laura E. Caulfield

Gillian Duffy

Vanessa Garcia-Larsen

Deborah Hayward

Matthew Hyde

Suzan Jeffries

Mikael Knip

Jo Leonardi-Bee

Elizabeth Loder

Caroline J. Lodge

Adrian J. Lowe

William McGuire

David Osborn

Hildegard Przyrembel

Mary J. Renfrew

Paula Trumbo

John Warner

Barbara Schneeman

Robert J. Boyle


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.

Journal Article Type Article
Publication Date May 11, 2020
Print ISSN 2168-6203
Electronic ISSN 2168-6211
Publisher American Medical Association
Peer Reviewed Peer Reviewed
APA6 Citation Jarrold, K., Helfer, B., Eskander, M., Crawley, H., Trabulsi, J., Caulfield, L. E., …Boyle, R. J. (2020). Guidance for the Conduct and Reporting of Clinical Trials of Breastmilk Substitutes: a Delphi Consensus Statement. JAMA Pediatrics,
Publisher URL