NCT06955715 Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
| NCT ID | NCT06955715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Saskatchewan |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-04-15 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pasteurized Donor Human Milk (PDHM) is recognized as providing vital immunological and nutritional benefits to vulnerable infants. Although PDHM is widely used in neonatal intensive care units (NICUs) to prevent infections (necrotizing enterocolitis) and improve infant health outcomes, its use for other populations, such as HIV-exposed infants, has been minimal. Pasteurized donor human milk is included in the 2023 Canadian Paediatric Society clinical consensus as a potential way to provide HIV-exposed infants some of the immunological benefits of human milk in a safe manner, as opposed to exclusive formula feeding (which is currently considered the gold standard for HIV-exposed infants). These new consensus guidelines also include recommendations to support those who wish to breastfeed using a harm reduction approach (e.g., increased viral load monitoring by peds infectious diseases), given the low risk of transmission in those adhering to antiretroviral medications. However, mixed feeding (e.g., breastfeeding and provision of infant formula) is not recommended, due to the potential for micro abrasions in the gastrointestinal epithelium as a result of the protein size in infant formula (which is larger and more abrasive than in human milk), which may increase the risk of HIV transmission if the HIV virus is present in breastmilk. As such, donor milk also presents a possible solution to support those who choose to breastfeed, but who may require a temporary supplement for whatever reason (e.g., nipple cracks, mastitis, etc.), as donor milk is human milk, thus has the same size of proteins and does not pose the same risk as infant formula in damaging the epithelial layer in the gut. Overall, major obstacles remain that prevent newborns outside of the NICU from regularly having access to donor human milk. These obstacles are illustrated by the high cost of donor milk, which is not covered by government programs, and the lack of information about the clinical benefits (for both those who choose to breastfeed or formula feed), acceptability of caregivers for this feeding option, and feasibility of providing donor human milk outside of a hospital setting. The investigators aim to determine whether giving PDHM to infants exposed to HIV is a practical possibility and learn from caregivers about any challenges associated with this feeding option. The results of this study will guide future research and a potential provincial initiative to expand access to PDHM for this population.
Eligibility Criteria
Inclusion criteria * ≥15 years of age * Pregnant or recently gave birth and living with HIV or is the primary caregivers of an HIV-exposed infant * Being followed by SHA Pediatric Infectious Disease * Saskatchewan resident (living within \~150 km from the University of Saskatchewan) * Have a household freezer * Willing to participate
Contact & Investigator
Kelsey M Cochrane, PhD
PRINCIPAL INVESTIGATOR
University of Saskatchewan
Frequently Asked Questions
Who can join the NCT06955715 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06955715 currently recruiting?
Yes, NCT06955715 is actively recruiting participants. Contact the research team at kelsey.cochrane@usask.ca for enrollment information.
Where is the NCT06955715 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT06955715 clinical trial?
NCT06955715 is sponsored by University of Saskatchewan. The principal investigator is Kelsey M Cochrane, PhD at University of Saskatchewan. The trial plans to enroll 10 participants.
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