Recruiting

Pasteurized Donor Milk

Sponsor:

University of Saskatchewan

Code:

NCT06955715

Conditions

HIV

Pregnancy

Breastfeeding

Infant Feeding Practices

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Pasteurized Donor Human Milk

Study Details

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.

Conditions

HIV

Pregnancy

Breastfeeding

Infant Feeding Practices

Study ID

NCT06955715

Start date

Apr 15, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pasteurized Donor Human Milk

Pasteurized donor human milk sourced from the Norther Star Mother's Milk Bank (Calgary, AB, Canada)

Interventions

Pasteurized Donor Human Milk

This is a single arm study in which all participants will receive pasteurized donor human milk sourced from the Norther Star Mother's Milk Bank (Calgary, AB, Canada)

Primary outcome measure

  • Frequency of PDHM provision (#/day) [ Time Frame: 8-12 week intervention period ]
  • Volume of PDHM provision (mL/day) [ Time Frame: 8-12 week intervention period ]

Central Contacts and Locations

Central contacts

Chloe Langen, MSc (Candidate)

(306) 537-2257Chloe.langen@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5A5

Contacts

Chloe Langen, MSc (Candidate)

306-537-2257Chloe.langen@usask.ca

Principal Investigator:

Kelsey M Cochrane, PhD

More Information

Sponsor

University of Saskatchewan

Last update posted

Nov 19, 2025

Last verified

Apr, 2025

Keywords

  • Donor Human Milk
  • HIV-Exposed Infants
  • Pasteurized Donor Milk
  • Infant Nutrition
  • Feasibility Study
  • HIV and Infant Feeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2025-11-19.