Pasteurized Donor Human Milk for HIV-Exposed Infants

Overseen By Chloe Langen, MSc (Candidate)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must be taking: Antiretrovirals

Disqualifiers: Under 15, Not HIV-exposed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6-8 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Pasteurized Donor Human Milk for HIV-Exposed Infants?

Research suggests that pasteurization of donor human milk can destroy the HIV-1 virus while retaining beneficial properties that may help infants of HIV-positive mothers, especially in areas where not breastfeeding poses a higher risk of infant mortality. ^{1 2 3 4 5}

Is pasteurized donor human milk safe for infants?

Pasteurized donor human milk is widely used for preterm infants and is considered safe, as pasteurization prevents bacterial contamination. Studies have shown that it is a safe alternative to formula, especially for premature babies, and milk banks have quality control measures to ensure safety. ^{1 6 7 8 9}

How is pasteurized donor human milk different from other treatments for HIV-exposed infants?

Pasteurized donor human milk is unique because it provides essential nutrients and immune components from human milk while reducing the risk of HIV transmission through pasteurization, unlike formula which lacks these bioactive components. This treatment is particularly beneficial when a mother's own milk is unavailable, offering a safer alternative to formula feeding for HIV-exposed infants. ^{1 7 10 11 12}

What is the purpose of 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.

Research Team

Kelsey M Cochrane, PhD

Principal Investigator

University of Saskatchewan

Eligibility Criteria

This trial is for HIV-exposed infants who may benefit from the immunological advantages of human milk without the risks associated with mixed feeding. The study aims to explore if pasteurized donor human milk can be a safe and practical alternative to formula feeding for these infants.

Inclusion Criteria

Pregnant or recently gave birth and living with HIV or is the primary caregiver of an HIV-exposed infant

Being followed by SHA Pediatric Infectious Disease

Saskatoon resident (living within ~25 km from the University of Saskatchewan)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pasteurized Donor Human Milk (PDHM) for 6-8 weeks, with home visits to deliver milk and track feeding habits

6-8 weeks

4 home visits

Follow-up

Participants are monitored for infant growth and health outcomes after the intervention period

4 weeks

Treatment Details

Interventions

• Pasteurized Donor Human Milk

Trial Overview The pilot study tests whether providing pasteurized donor human milk (PDHM) to HIV-exposed infants is feasible, acceptable to caregivers, and beneficial outside of NICU settings. It seeks alternatives to exclusive formula feeding, following new guidelines that favor PDHM over mixed feeding.

Participant Groups

Group I: Pasteurized Donor Human Milk Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Findings from Research

A study of 25 samples of donor human milk (DHM) showed that key nutrients like lactose, protein, and immunoglobulin A (IgA) remained stable over 4 days of refrigerated storage, indicating that DHM maintains its nutritional quality during this time.

DHM consistently had low levels of aerobic bacteria after pasteurization, with 81% of samples showing less than 102 colony-forming units (CFUs), while infant formula had significantly higher bacterial counts, suggesting that DHM is a safer option for infants in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Refrigerated Storage of Donor Human Milk with Limited Bacterial Presence After Holder Pasteurization on Nutrient Concentration and Bacterial Growth. McCune, S., Perrin, M.[2023]

Pasteurized donor human milk is essential for preterm infants in neonatal intensive care units to prevent bacterial contamination, but the pasteurization process alters its nutrient and bioactive components compared to unpasteurized milk.

Different pasteurization methods (Holder, vat, and retort) and practices like freezing and pooling from multiple donors significantly impact the nutritional composition of donor milk, which is crucial for the health of vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of milk banking procedures on nutritional and bioactive components of donor human milk. Colaizy, TT.[2021]

In a survey of 71 hospitals in the northeast United States, 29% of Massachusetts birth hospitals and 43% of hospitals served by a milk bank reported using pasteurized donor human milk for healthy newborns, indicating a significant adoption of this practice.

Hospitals that utilized donor milk had a higher rate of exclusive breastfeeding at discharge (77% vs. 56%), suggesting that donor milk may support breastfeeding efforts in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Trends in Donor Milk Use in the Well-Baby Nursery: A Survey of Northeast United States Birth Hospitals. Belfort, MB., Drouin, K., Riley, JF., et al.[2019]

Donor human milk is considered a safe and effective alternative for feeding extremely preterm infants when their mother's milk is not available, supported by clinical data on its benefits.

The article proposes a risk assessment methodology for milk banks worldwide to evaluate and enhance the safety of their processes, ensuring quality control in donor selection and pasteurization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. Landers, S., Hartmann, BT.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Viral, nutritional, and bacterial safety of flash-heated and pretoria-pasteurized breast milk to prevent mother-to-child transmission of HIV in resource-poor countries: a pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of pasteurization on selected immune components of donated human breast milk. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

The Effects of Refrigerated Storage of Donor Human Milk with Limited Bacterial Presence After Holder Pasteurization on Nutrient Concentration and Bacterial Growth. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Transmission of HIV-1 in the breast-feeding process. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Donor milk intake and infant growth in a South African neonatal unit: a cohort study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mother-to-infant transmission of human immunodeficiency virus by breast milk: presumed innocent or presumed guilty? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of milk banking procedures on nutritional and bioactive components of donor human milk. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prevalence and Trends in Donor Milk Use in the Well-Baby Nursery: A Survey of Northeast United States Birth Hospitals. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

A Descriptive Study of the Attitudes, Perceptions, and Experiences of Human Milk Donation. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Milking the System: A Case Study of Donor Milk for a Child in Foster Care. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Effect of pasteurization on immune components of milk: implications for feeding preterm infants. [2016]