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

NCT06955715 | Recruiting

• 1 other identifier: 106702
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Frequency of PDHM provision (#/day)

  Frequency (# of PDHM feedings/day) of PDHM provided to infants as a top up to infant formula or while breastfeeding

  8-12 week intervention period

• Volume of PDHM provision (mL/day)

  Volume (mL/day) of PDHM provided to infants as a top up to infant formula or while breastfeeding

  8-12 week intervention period

Secondary Outcomes (2)

• Events of infant intolerance (n, %)

  8-12 weeks

• Caregiver-related experiences and challenges

  8-12 weeks

Other Outcomes (2)

• Infant growth (g/day)

  8-12 weeks

• Frequency of illness or opportunistic infections (n, %)

  8-12 weeks

Study Arms (1)

Pasteurized Donor Human Milk

EXPERIMENTAL

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

Other: Pasteurized Donor Human Milk

Interventions

Pasteurized Donor Human Milk OTHER

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)

Pasteurized Donor Human Milk

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Kelsey M Cochrane, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey M Cochrane, PhD

CONTACT

(306) 966-1310; kelsey.cochrane@usask.ca

Chloe Langen, MSc (Candidate)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a single-group design where HIV-exposed infants receive pasteurized donor human milk as a supplement to infant formula or to support exclusive breastfeeding.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 2, 2025
• Study Start: April 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-04

Locations

CA (1)