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

November 15, 2025 updated by: Kelsey Cochrane, University of Saskatchewan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will recruit women living with HIV who recently gave birth (or caregivers of HIV-exposed infants) living in Saskatoon, SK, Canada, and surrounding areas who are being followed by the Saskatchewan Health Authority (SHA) Pediatric Infectious Diseases. Women/caregivers may be currently formula feeding or breastfeeding their infant. PDHM will be provided to participants for a period of ~6-8 weeks (starting at ~2 months postpartum) and will involve 4 home visits to deliver PDHM in intervals of ~2-3 weeks and track feeding habits, as described below.

Visit 1 (Baseline; ~2 months postpartum): Deliver frozen PDHM to participant homes. For those who are formula feeding, we will provide 25 x 120 mL bottles, and for those who are breastfeeding, we will provide 8 x 120 mL bottles. Those who are formula feeding will be instructed to provide ~1-2 bottles of PDHM daily as a top-up to infant formula. Those who are breastfeeding will be instructed to provide PDHM as needed, if a supplement to breastfeeding is required for any reason (as opposed to supplementing with infant formula, which is not recommended for those breastfeeding). Caregivers will log the amount of PDHM given daily, any challenges, and any signs of poor tolerance (e.g., fussiness, vomiting, diarrhea). A baseline questionnaire will be given to collect demographic characteristics about the caregiver and birth data. Infant weight will be measured using a portable infant scale to establish a baseline for growth tracking.

Visit 2 (2-3 weeks) and Visit 3 (4-6 weeks): Collect all empty bottles from previous visits and completed tracking documents. Deliver a new batch of PDHM (quantities as described above).

Visit 4 (6-8 weeks; ~4 months postpartum): Collect all remaining empty bottles and final tracking documents. Infant weight using a portable infant scale will be measured to assess growth over the study period.

Participants will also receive a weekly check-in (phone call) to discuss any questions and gather general updates/information on infant feeding practices.

The investigators will further collect infant health related data collected by SHA Peds Infectious Disease as part of routine appointments. This will include anthropometric measurements (e.g., weight, height, head circumference) and occurrences of illness or opportunistic infections from birth to 4 months.

Statistical Analysis: We will calculate the mean ± SD (or median, IQR) for the frequency of donor milk provision (# of donor milk feedings/day) and volume (donor milk mL/day) based tracking documents; empty bottle counts will be used as a secondary estimate. Events of poor tolerance (e.g., colic, fussiness, vomiting) will be summarized using absolute frequencies and percentages. Any open-ended comments re: challenges, tolerance, or general thoughts re: provision of donor milk, will be categorized to identify trends among study participants. Clinical pilot data will include infant growth (e.g., mean ± SD daily weight gain velocity, percentiles for length-for-age, weight-for-age, head circumference, and weight-for-length) and reported rates of illness or infections, based on Pediatric Infectious Disease records.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5A5
        • Recruiting
        • University of Saskatchewan
        • Contact:
        • Principal Investigator:
          • Kelsey M Cochrane, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pasteurized Donor Human Milk
Pasteurized donor human milk sourced from the Norther Star Mother's Milk Bank (Calgary, AB, Canada)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of PDHM provision (#/day)
Time Frame: 8-12 week intervention period
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)
Time Frame: 8-12 week intervention period
Volume (mL/day) of PDHM provided to infants as a top up to infant formula or while breastfeeding
8-12 week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Events of infant intolerance (n, %)
Time Frame: 8-12 weeks
Participant reported events of poor tolerance (including gas, vomiting, diarrhea, etc.) which occur while providing the intervention (PDHM)
8-12 weeks
Caregiver-related experiences and challenges
Time Frame: 8-12 weeks
Open-ended comments from caregivers regarding any concerns with PDHM provision (such as storage, thawing, preparation, or infant tolerance).
8-12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant growth (g/day)
Time Frame: 8-12 weeks
Infant growth (g/d weight gain) from visit 1 to visit 4 (baseline to endline)
8-12 weeks
Frequency of illness or opportunistic infections (n, %)
Time Frame: 8-12 weeks
Rates of illness or opportunistic infection throughout the intervention period.
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Kelsey M Cochrane, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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