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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pasteurized donor human milk (PDHM) can be a practical and beneficial option for infants exposed to HIV. Researchers aim to determine if PDHM offers important immune and nutritional benefits compared to exclusive formula feeding, the current standard. They also seek caregiver feedback on any challenges in using PDHM. The study is recruiting Saskatoon residents who care for an HIV-exposed infant, have a household freezer, and are willing to participate. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance infant care options.

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 prior data suggests that pasteurized donor human milk is safe for HIV-exposed infants?

Research shows that pasteurized donor human milk (PDHM) is safe and offers important benefits for babies, particularly those who are more vulnerable. Studies have found that PDHM contains very low or undetectable levels of germs that can cause infections, making it a safe option for feeding babies, including those exposed to HIV.

PDHM is recommended because it eliminates the risk of HIV transmission, similar to formula feeding. This is crucial for babies whose mothers are HIV-positive. Hospitals commonly use PDHM to provide essential nutrients and immune support to babies, especially in neonatal intensive care units (NICUs).

Overall, PDHM is considered safe and well-tolerated by babies. Its safety, along with its nutritional and immune benefits, makes it a valuable choice for feeding babies, especially when breastfeeding is not possible or needs supplementation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for HIV-exposed infants focus on antiretroviral drugs to prevent transmission. However, pasteurized donor human milk offers a unique nutritional approach. Unlike formula or mixed feeding options, this milk is sourced from donor mothers and is pasteurized to ensure safety. It's rich in antibodies and essential nutrients, which can support the infant's immune system and overall health. Researchers are excited because it might provide additional protection and health benefits that standard feeding options can't match.

What evidence suggests that pasteurized donor human milk might be an effective treatment for HIV-exposed infants?

Research has shown that pasteurized donor human milk (PDHM) provides significant immune and nutritional benefits for vulnerable infants. Hospitals frequently use PDHM to protect premature babies from infections such as necrotizing enterocolitis, a serious gut condition. For infants exposed to HIV, PDHM serves as a safe feeding option, as it eliminates the risk of HIV transmission associated with breastfeeding without precautions. Clinical guidelines now recommend PDHM as an alternative to formula for HIV-exposed infants, offering benefits similar to breastmilk without the risks associated with formula. Additionally, PDHM can temporarily supplement those who choose to breastfeed but require extra support. ^{1 2 4 6 7}

Who Is on the Research Team?

Kelsey M Cochrane, PhD

Principal Investigator

University of Saskatchewan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06955715

Pasteurized Donor Human Milk for HIV-Exposed Infants: A ...

Pasteurized Donor Human Milk (PDHM) is recognized as providing vital immunological and nutritional benefits to vulnerable infants.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12527334/

Adoption of the Revised DHHS Guidelines on Breastmilk ...

Concern for HIV transmission was the strongest barrier to supporting breastmilk feeding across both subspecialties and all geographical regions, ...

3.

clinicalinfo.hiv.gov

clinicalinfo.hiv.gov/en/guidelines/perinatal/preventing-transmission-infant-feeding

Infant Feeding for People With HIV in the United States | NIH

Replacement feeding with properly prepared formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831322005865

Current Knowledge and Future Research on Infant ...

To that end, in 1998, WHO, UNICEF, and UNAIDS issued a series of documents stating that replacement-fed, HIV-exposed infants were less at risk of illness and ...

5.

publications.aap.org

publications.aap.org/pediatrics/article/139/1/e20163440/52000/Donor-Human-Milk-for-the-High-Risk-Infant

Donor Human Milk for the High-Risk Infant

The use of donor human milk is increasing for high-risk infants, primarily for infants born weighing <1500 g or those who have severe intestinal disorders.

6.

cdc.gov

cdc.gov/breastfeeding-special-circumstances/hcp/illnesses-conditions/hiv.html

HIV and Breastfeeding

Replacing breastfeeding with properly prepared formula or pasteurized donor human milk from a milk bank. This eliminates the risk of HIV ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10776031/

2023 Updated Guidelines on Infant Feeding and HIV in the ...

The infant feeding options that eliminate the risk of HIV transmission are formula and pasteurized donor human milk. Fully suppressive antiretroviral ...