Pasteurised donor human milk for HIV-exposed infants in Saskatchewan, Canada: a feasibility trial protocol

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.

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 ≥15 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 months 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 2-3 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.

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.

NCT06955715.