Testing Pasteurized Donor Human Milk for HIV
Official title: Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
- 1 group
- One site, in Saskatoon
- Recruiting
Interventions
- Other intervention
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)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +≥15 years of age
- +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
- +Pregnant or recently gave birth and living with HIV or is the primary caregivers of an HIV-exposed infant
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Pasteurized Donor Human Milk.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 15 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 8-12 week intervention period.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Frequency of PDHM provision (#/day) — measured over 8-12 week intervention period.
Volume of PDHM provision (mL/day) — measured over 8-12 week intervention period.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06955715 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 15 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 15 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 8-12 week intervention period.
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Saskatoon, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.