{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:55Z","timestamp":1792787275417,"version":"4.5.0"},"reference-count":50,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"unspecified","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Saskatchewan Health Research Foundation","award":["Solutions Program Innovation Grant (2024)"],"award-info":[{"award-number":["Solutions Program Innovation Grant (2024)"]}],"id":[{"id":"https:\/\/ror.org\/00trnds81","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,9,4]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Pasteurised donor human milk (PDHM) provides nutritional and immunological benefits for vulnerable infants, yet its use remains largely restricted to neonatal intensive care units. The protective effects of PDHM are well established for preterm and very low birth weight infants, but little is known about its feasibility and acceptability for other populations, including HIV-exposed infants. In high-income countries, infant feeding guidelines historically prioritised exclusive formula feeding to eliminate HIV transmission through breast milk. More recently, guidance has incorporated harm-reduction strategies supporting breastfeeding under specific conditions and recognising PDHM as an option when maternal milk is unavailable. However, evidence on PDHM use for HIV-exposed infants outside hospital settings remains limited. This study explores caregiver acceptability and practical considerations related to providing PDHM in community settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This single-arm feasibility trial aims to recruit 10 caregivers of HIV-exposed infants through the Saskatchewan Health Authority Pediatric Infectious Disease unit. Eligible caregivers will be \u226515 years of age and residents of Saskatchewan. Participants will complete four home visits over the study period. Baseline home visits will occur when infants are approximately 2\u2009months of age, during which frozen PDHM will be delivered to homes. PDHM will be used as a supplement to infant formula or breastfeeding. Caregivers will record PDHM usage and infant tolerance using structured tracking forms. Follow-up visits will occur every 2\u20133 weeks for PDHM delivery and bottle counts, with weekly check-ins for support. Clinical pilot data will include infant anthropometrics and serious illness events collected during study visits and abstracted from medical records. Descriptive analyses will summarise PDHM intake, tolerance and caregiver experiences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was obtained from the University of Saskatchewan Biomedical Research Ethics Board (BIO 5307) and the Saskatchewan Health Authority. Findings will be disseminated through peer-reviewed publications and conference presentations.<\/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=\"NCT06955715\">NCT06955715<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-120638","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T14:28:36Z","timestamp":1790000916000},"page":"e120638","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Pasteurised donor human milk for HIV-exposed infants in Saskatchewan, Canada: a feasibility trial protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06955715","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-7659-2298","authenticated-orcid":false,"given":"Chloe","family":"Langen","sequence":"first","affiliation":[{"name":"College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7831-5913","authenticated-orcid":false,"given":"David","family":"Blackburn","sequence":"additional","affiliation":[{"name":"College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupeena","family":"Purewal","sequence":"additional","affiliation":[{"name":"College of Medicine, University of Saskatchewan, Saskatoon, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey M","family":"Cochrane","sequence":"additional","affiliation":[{"name":"College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,21]]},"reference":[{"key":"2026092107253119000_16.9.e120638.1","first-page":"7","article-title":"Canadian Pediatric & Perinatal HIV\/AIDS Research Group consensus recommendations for infant feeding in the HIV context","volume":"8","author":"Khan","year":"2023","journal-title":"J Assoc Med Microbiol Infect Dis Can"},{"key":"2026092107253119000_16.9.e120638.2","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2022-057988","article-title":"Policy Statement: Breastfeeding and the Use of Human Milk","volume":"150","author":"Meek","year":"2022","journal-title":"Pediatrics"},{"key":"2026092107253119000_16.9.e120638.3","unstructured":"Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission . Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal hiv transmission in the united states. Department of Health and Human Services. Available: https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/perinatal [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.4","unstructured":"International Antiviral Society\u2013USA Panel . The us department of health and human services guidelines on infant feeding among people with hiv have changed. Available: https:\/\/www.iasusa.org [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.5","unstructured":"Centers for Disease Control and Prevention . HIV and breastfeeding. 2025. Available: https:\/\/www.cdc.gov\/breastfeeding-special-circumstances\/hcp\/illnesses-conditions\/hiv.html [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.6","unstructured":"British HIV Association . BHIVA guidelines for the management of hiv in pregnancy and postpartum. Available: https:\/\/www.bhiva.org [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.7","doi-asserted-by":"crossref","first-page":"1515","DOI":"10.1111\/hiv.70072","article-title":"European Guidelines on HIV and breastfeeding: \u201cSame, same, but different\u201d - Results from a WAVE survey","volume":"26","author":"Keane","year":"2025","journal-title":"HIV Med"},{"key":"2026092107253119000_16.9.e120638.8","unstructured":"European milk bank association. Available: https:\/\/europeanmilkbanking.com [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.9","unstructured":"Global foundation for the care of newborn infants. Available: https:\/\/www.gfcni.org [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.10","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2008.0114"},{"key":"2026092107253119000_16.9.e120638.11","doi-asserted-by":"publisher","DOI":"10.4137\/NMI.S29530"},{"key":"2026092107253119000_16.9.e120638.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2007.11.014"},{"key":"2026092107253119000_16.9.e120638.13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(99)01101-0"},{"key":"2026092107253119000_16.9.e120638.14","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60283-9"},{"key":"2026092107253119000_16.9.e120638.15","doi-asserted-by":"publisher","DOI":"10.14745\/ccdr.v45i12a01"},{"key":"2026092107253119000_16.9.e120638.16","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1111\/hiv.13346","article-title":"Prescribing patterns of antiretroviral treatments during pregnancy for women living with HIV in Canada 2004-2020: A surveillance study","volume":"24","author":"Carvalho","year":"2023","journal-title":"HIV Med"},{"key":"2026092107253119000_16.9.e120638.17","doi-asserted-by":"publisher","DOI":"10.1111\/cei.12251"},{"key":"2026092107253119000_16.9.e120638.18","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2016.00310","article-title":"Linking Susceptibility to Infectious Diseases to Immune System Abnormalities among HIV-Exposed Uninfected Infants","volume":"7","author":"Ruck","year":"2016","journal-title":"Front Immunol"},{"key":"2026092107253119000_16.9.e120638.19","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1093\/cid\/ciz820","article-title":"Rates of Hospitalization and Infection-Related Hospitalization Among Human Immunodeficiency Virus (HIV)-Exposed Uninfected Children Compared to HIV-Unexposed Uninfected Children in the United States, 2007-2016","volume":"71","author":"Labuda","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2026092107253119000_16.9.e120638.20","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001211"},{"key":"2026092107253119000_16.9.e120638.21","doi-asserted-by":"crossref","first-page":"2327","DOI":"10.1097\/QAD.0000000000003039","article-title":"Increased infectious-cause hospitalization among infants who are HIV-exposed uninfected compared with HIV-unexposed","volume":"35","author":"Anderson","year":"2021","journal-title":"AIDS"},{"key":"2026092107253119000_16.9.e120638.22","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2016.00164","article-title":"Pattern of Infectious Morbidity in HIV-Exposed Uninfected Infants and Children","volume":"7","author":"Slogrove","year":"2016","journal-title":"Front Immunol"},{"key":"2026092107253119000_16.9.e120638.23","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1111\/tmi.12695","article-title":"Mortality risk and associated factors in HIV-exposed, uninfected children","volume":"21","author":"Arikawa","year":"2016","journal-title":"Trop Med Int Health"},{"key":"2026092107253119000_16.9.e120638.24","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.16144"},{"key":"2026092107253119000_16.9.e120638.25","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000007970","article-title":"A retrospective study on the effects of exclusive donor human milk feeding in a short period after birth on morbidity and growth of preterm infants during hospitalization","volume":"96","author":"Kim","year":"2017","journal-title":"Medicine (Baltimore)"},{"key":"2026092107253119000_16.9.e120638.26","doi-asserted-by":"crossref","DOI":"10.3389\/fmicb.2018.01376","article-title":"Preterm Gut Microbiome Depending on Feeding Type: Significance of Donor Human Milk","volume":"9","author":"Parra-Llorca","year":"2018","journal-title":"Front Microbiol"},{"key":"2026092107253119000_16.9.e120638.27","doi-asserted-by":"crossref","unstructured":"Quigley M , McGuire W . Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev 2014.:CD002971. doi:10.1002\/14651858.CD002971.pub3","DOI":"10.1002\/14651858.CD002971.pub3"},{"key":"2026092107253119000_16.9.e120638.28","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01024-7"},{"key":"2026092107253119000_16.9.e120638.29","doi-asserted-by":"publisher","DOI":"10.1126\/science.aaw6147"},{"key":"2026092107253119000_16.9.e120638.30","doi-asserted-by":"publisher","DOI":"10.1111\/apa.13147"},{"key":"2026092107253119000_16.9.e120638.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.earlhumdev.2015.09.001"},{"key":"2026092107253119000_16.9.e120638.32","doi-asserted-by":"publisher","DOI":"10.1093\/nutrit\/nuu016"},{"key":"2026092107253119000_16.9.e120638.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.clp.2016.11.008"},{"key":"2026092107253119000_16.9.e120638.34","doi-asserted-by":"publisher","DOI":"10.1016\/j.pcl.2012.10.002"},{"key":"2026092107253119000_16.9.e120638.35","doi-asserted-by":"publisher","DOI":"10.1016\/j.jada.2008.10.008"},{"key":"2026092107253119000_16.9.e120638.36","doi-asserted-by":"crossref","first-page":"2622","DOI":"10.1016\/j.tjnut.2023.07.012","article-title":"Nutrient Composition of Donor Human Milk and Comparisons to Preterm Human Milk","volume":"153","author":"Gates","year":"2023","journal-title":"J Nutr"},{"key":"2026092107253119000_16.9.e120638.37","doi-asserted-by":"crossref","first-page":"1785","DOI":"10.1002\/jpen.2073","article-title":"Term Infants Fed Exclusively With Donor Milk May Require Vitamin C Supplementation","volume":"45","author":"Castro","year":"2021","journal-title":"J Parenter Enteral Nutr"},{"key":"2026092107253119000_16.9.e120638.38","doi-asserted-by":"crossref","first-page":"140973","DOI":"10.1016\/j.foodchem.2024.140973","article-title":"Comparative proteomic analysis of donor human milk treated by high-pressure processing or Holder pasteurization on undigested proteins across dynamic simulated preterm infant digestion","volume":"462","author":"Pitino","year":"2025","journal-title":"Food Chem"},{"key":"2026092107253119000_16.9.e120638.39","doi-asserted-by":"publisher","DOI":"10.3345\/cep.2020.00059"},{"key":"2026092107253119000_16.9.e120638.40","doi-asserted-by":"crossref","first-page":"1720","DOI":"10.1007\/s10461-015-1023-0","article-title":"HIV Among Indigenous peoples: A Review of the Literature on HIV-Related Behaviour Since the Beginning of the Epidemic","volume":"19","author":"Negin","year":"2015","journal-title":"AIDS Behav"},{"key":"2026092107253119000_16.9.e120638.41","unstructured":"Public Health Agency of Canada . HIV in canada: surveillance report, 2021. Ottawa (ON): Government of Canada; 2023. Available: https:\/\/www.canada.ca\/en\/public-health\/services\/publications\/diseases-conditions\/hiv-in-canada-surveillance.html [accessed 11 Nov 2025]"},{"key":"2026092107253119000_16.9.e120638.42","doi-asserted-by":"crossref","first-page":"521","DOI":"10.1016\/j.jogc.2022.01.009","article-title":"Integrated Prenatal Care for Women Living With HIV: Primary Care Outcomes in Saskatoon, Saskatchewan","volume":"44","author":"Cozart","year":"2022","journal-title":"J Obstet Gynaecol Can"},{"key":"2026092107253119000_16.9.e120638.43","doi-asserted-by":"crossref","DOI":"10.4212\/cjhp.3572","article-title":"Overcoming Challenges during Breastfeeding to Prevent Perinatal HIV Transmission in Canada: A Case Series","volume":"77","author":"Lam","year":"2024","journal-title":"Can J Hosp Pharm"},{"key":"2026092107253119000_16.9.e120638.44","unstructured":"NorthernStar Mothers Milk Bank . About us. Calgary (AB): NorthernStar Mothers Milk Bank. Available: https:\/\/northernstarmilkbank.ca [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.45","doi-asserted-by":"publisher","DOI":"10.1016\/j.earlhumdev.2009.08.010"},{"key":"2026092107253119000_16.9.e120638.46","unstructured":"Human Milk Banking Association of North America . Guidelines for the establishment and operation of a donor human milk bank. Fort Worth (TX): HMBANA; 2023. Available: https:\/\/www.hmbana.org [Accessed 11 Nov 2025]."},{"key":"2026092107253119000_16.9.e120638.47","doi-asserted-by":"crossref","DOI":"10.3390\/nu8080477","article-title":"The Effect of Holder Pasteurization on Nutrients and Biologically-Active Components in Donor Human Milk: A Review","volume":"8","author":"Peila","year":"2016","journal-title":"Nutrients"},{"key":"2026092107253119000_16.9.e120638.48","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.i5239","article-title":"CONSORT 2010 statement: extension to randomised pilot and feasibility trials","volume":"355","author":"Eldridge","year":"2016","journal-title":"BMJ"},{"key":"2026092107253119000_16.9.e120638.49","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2024-083405","article-title":"Determining sample size for pilot trials: a tutorial","volume":"390","author":"Ying","year":"2025","journal-title":"BMJ"},{"key":"2026092107253119000_16.9.e120638.50","doi-asserted-by":"crossref","first-page":"2","DOI":"10.3390\/laws12010002","article-title":"Adolescent Capacity to Consent to Participate in Research: A Review and Analysis Informed by Law, Human Rights, Ethics, and Developmental Science","volume":"12","author":"Mathews","year":"2023","journal-title":"Laws"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-120638","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T14:28:45Z","timestamp":1790000925000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-120638"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":50,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,21]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1136\/bmjopen-2026-120638"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-120638","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}