NCT06955715

Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study

Recruiting now NA Last updated 19 November 2025

What this trial tests

NA trial testing Pasteurized Donor Human Milk in HIV in 10 participants. Currently enrolling.

Timeline

15 April 2025

Primary endpoint
1 May 2026

31 December 2026

Quick facts

Lead sponsor	University of Saskatchewan
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	15 April 2025
Primary completion	1 May 2026
Estimated completion	31 December 2026
Sites	1 location across Canada

Drugs / interventions tested

• Pasteurized Donor Human Milk

Conditions studied

• HIV — all drugs for HIV →
• Pregnancy — all drugs for Pregnancy →
• Breastfeeding — all drugs for Breastfeeding →
• Infant Feeding Practices — all drugs for Infant Feeding Practices →

Sponsor

University of Saskatchewan

Who can join

15 and older, any sex, with HIV or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.