{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:54Z","timestamp":1792787274767,"version":"4.5.0"},"reference-count":56,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T00:00:00Z","timestamp":1789430400000},"content-version":"unspecified","delay-in-days":14,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Academic Health Sciences Centre Alternate Funding Plan (AHSC AFP) Innovation Fund","award":["410019218"],"award-info":[{"award-number":["410019218"]}],"id":[{"id":"https:\/\/ror.org\/05pr37258","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100004489","name":"Mitacs","doi-asserted-by":"publisher","award":["IT32497"],"award-info":[{"award-number":["IT32497"]}],"id":[{"id":"10.13039\/501100004489","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,21]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Mother\u2019s milk is the gold standard for feeding newborns. Despite lactation support while in hospital, supplementation rates remain high in Canadian well-baby units at 35\u201350%. When supplementation is needed, the choice between formula milk and pasteurised human donor milk (donor milk) remains uncertain with a lack of clinical trials to inform this practice. This study aims to compare the effect of supplementing mother\u2019s milk with donor milk versus formula in infants at higher risk for supplementation (infants of diabetic mothers, infants born small for gestational age or with a birth weight less than 2.5\u2009kg and late preterm infants born between 35\n                      <jats:sup>0\/7<\/jats:sup>\n                      and 36\n                      <jats:sup>6\/7<\/jats:sup>\n                      weeks gestation).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital, Toronto, Canada. A total of 112 infants (56 per group) will be randomised to receive donor milk or infant formula as a supplement to mother\u2019s milk during their initial hospital stay, when supplementation is deemed necessary by the family and\/or healthcare team. The primary outcome is exclusive human milk feeding at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months; infant growth and health indicators and breastfeeding self-efficacy. Exploratory outcomes encompass infant temperament; parental mental health (assessed using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale); milk cortisol concentrations; and informal milk sharing comparing donor milk and formula supplementation. Follow-up includes monthly telephone assessments and a virtual or in-person visit at 4 months post partum. Data will be analysed using intention-to-treat principles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. Results will be disseminated through peer-reviewed journals, conference presentations and stakeholder engagement with hospital and public health decision-makers. Findings will address a critical evidence gap regarding the use of donor milk supplementation in well-baby units and may inform future clinical practice and policy in newborn feeding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06315127\">NCT06315127<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-114973","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T14:01:18Z","timestamp":1789480878000},"page":"e114973","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["CanDo (Canadian Donor Milk) randomised controlled trial: pasteurised human donor milk supplementation in the well-baby unit \u2013 protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06315127","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06315127","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3801-2029","authenticated-orcid":false,"given":"Maryam","family":"Razaghi","sequence":"first","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medecine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Paediatrics, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6331-091X","authenticated-orcid":false,"given":"Deborah L","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medecine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Paediatrics, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1289-1299","authenticated-orcid":false,"given":"Jyotsna","family":"Shah","sequence":"additional","affiliation":[{"name":"Paediatrics, Sinai Health, Toronto, Ontario, Canada"},{"name":"Paediatrics, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Leibson","sequence":"additional","affiliation":[{"name":"Paediatrics, Sinai Health, Toronto, Ontario, Canada"},{"name":"Paediatrics, University of Toronto, Toronto, Ontario, Canada"},{"name":"Rogers Hixon Ontario Human Milk Bank, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Dart","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Women\u2019s and Infants Health Program, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Da Silva","sequence":"additional","affiliation":[{"name":"Paediatrics, Sinai Health, Toronto, Ontario, Canada"},{"name":"Rogers Hixon Ontario Human Milk Bank, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"O\u2019born","sequence":"additional","affiliation":[{"name":"Rogers Hixon Ontario Human Milk Bank, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3373-4939","authenticated-orcid":false,"given":"Alex","family":"Kiss","sequence":"additional","affiliation":[{"name":"Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debbie","family":"Stone","sequence":"additional","affiliation":[{"name":"Rogers Hixon Ontario Human Milk Bank, Sinai Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8091-5742","authenticated-orcid":false,"given":"Sharon","family":"Unger","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medecine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Rogers Hixon Ontario Human Milk Bank, Sinai Health, Toronto, Ontario, Canada"},{"name":"Neonatal-Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,15]]},"reference":[{"key":"2026091507005011000_16.9.e114973.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01024-7"},{"key":"2026091507005011000_16.9.e114973.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)01932-8"},{"key":"2026091507005011000_16.9.e114973.3","unstructured":"World Health Organization . 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