HIVNCT06955715
Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
A study testing Pasteurized Donor Human Milk in people with HIV and Pregnancy, run by University of Saskatchewan at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV, Pregnancy, Breastfeeding
- What is being tested?
- Pasteurized Donor Human Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A5
Chloe Langen, MSc (Candidate), 306-537-2257, Chloe.langen@usask.ca
Kelsey M Cochrane, PhD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- HIV, Pregnancy, Breastfeeding, Infant Feeding Practices
- Being tested
- Pasteurized Donor Human Milk
- Keywords
- Donor Human Milk, HIV-Exposed Infants, Pasteurized Donor Milk, Infant Nutrition, Feasibility Study, HIV and Infant Feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized Donor Human MilkOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Pasteurized Donor Human Milk | Experimental | Pasteurized donor human milk sourced from the Norther Star Mother's Milk Bank (Calgary, AB, Canada) Receives: Other: Pasteurized Donor Human Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8-12 week intervention period
Secondary outcomes (2)
Events of infant intolerance (n, %)
Participant reported events of poor tolerance (including gas, vomiting, diarrhea, etc.) which occur while providing the intervention (PDHM)
Measured: 8-12 weeks
Caregiver-related experiences and challenges
Open-ended comments from caregivers regarding any concerns with PDHM provision (such as storage, thawing, preparation, or infant tolerance).
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Cochrane, University of Saskatchewan
- Investigators
- Kelsey M Cochrane, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955715
- Sponsor's protocol ID
- 106702
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langen C, Blackburn D, Purewal R, Cochrane KM. Pasteurised donor human milk for HIV-exposed infants in Saskatchewan, Canada: a feasibility trial protocol. BMJ Open. 2026 Sep 21;16(9):e120638. doi: 10.1136/bmjopen-2026-120638.
PubMed 42767755
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
- ClinicalTrials.gov ID
- NCT06955715
- Acronym / sponsor ID
- 106702
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pasteurized Donor Human Milk | Experimental | Other: Pasteurized Donor Human MilkPasteurized donor human milk sourced from the Norther Star Mother's Milk Bank (Calgary, AB, Canada) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasteurized Donor Human MilkThis 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) | Other | Pasteurized Donor Human Milk |
Primary outcome
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
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
2 secondary outcomes
Events of infant intolerance (n, %)
Time frame: 8-12 weeks
Caregiver-related experiences and challenges
Time frame: 8-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 42767755Langen C, Blackburn D, Purewal R, Cochrane KM. Pasteurised donor human milk for HIV-exposed infants in Saskatchewan, Canada: a feasibility trial protocol. BMJ Open. 2026 Sep 21;16(9):e120638. doi: 10.1136/bmjopen-2026-120638.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelsey M Cochrane, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized Donor Human Milk in people with HIV and Pregnancy, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey M Cochrane, PhD ((306) 966-1310, kelsey.cochrane@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of PDHM provision (#/day) (time frame: 8-12 week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.