Donor Milk for Newborns

Recruiting at 2 trial locations

Overseen By Sharon Unger, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Other study, Caregiver change, others

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

Compensation: Varies

Number of Visits: 4

Duration: From birth to 72 hours after delivery or until discharge

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how donor milk compares to formula in supporting breastfeeding and health outcomes for newborns needing extra feeding. It focuses on infants born to diabetic mothers or those born smaller than average, specifically under 2.5 kg. Researchers will randomly assign babies to receive either pasteurized donor milk from a milk bank or standard infant formula. The goal is to determine if donor milk can increase the duration and exclusivity of breastfeeding, while also assessing its effects on growth, behavior, feeding efficiency, and parental stress. As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of donor milk for newborns.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that donor human milk is generally safe for babies, particularly those requiring extra care. Milk banks enforce strict guidelines to screen donors and ensure milk safety, including pasteurization to eliminate harmful germs. Studies have found that donor milk can protect babies from infections and other health issues.

While there are some risks, such as potential exposure to infections or contaminants, these are rare due to the rigorous safety checks. Overall, donor milk is considered a well-tolerated option for feeding infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about human donor milk for newborns because it offers a natural alternative to formula, which is the standard supplement for infants needing extra feeding. Human donor milk is unique because it contains bioactive components and immune-protective factors that formula lacks. These elements can support the development of a baby's immune system and gut health more effectively than formula. Additionally, donor milk is pasteurized to ensure safety while preserving key nutrients, offering a promising option for enhancing newborn nutrition and overall health.

What evidence suggests that this trial's treatments could be effective for newborns?

Research has shown that human donor milk, under study in this trial, can help prevent serious health issues in premature babies, such as necrotizing enterocolitis, a severe intestinal disease. Studies have found that premature infants receiving donor milk have half the risk of developing this condition compared to those fed formula, which serves as the standard of care and another treatment arm in this trial. Donor milk also correlates with lower chances of lung problems and blood infections. While these benefits primarily appear in premature babies, they may also assist any newborn needing extra feeding, especially those smaller than average for their age. ^{4 6 7 8 9}

Who Is on the Research Team?

Sharon Unger, MD

Principal Investigator

Sinai Health

Deborah O'Connor, PhD, RD

Principal Investigator

Chair, Department of Nutritional Sciences, University of Toronto

Are You a Good Fit for This Trial?

This trial is for newborns born to mothers with any type of diabetes or babies who are small for their gestational age (less than 2500 grams). The infants must be in a well-baby unit and require supplementation. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

My baby was born smaller than most other babies at the same number of weeks of pregnancy.

Infants of gestational/type 1/type 2 diabetic mothers

Infants admitted to the well-baby unit at Sinai Health whose parent(s) intend to feed parent milk and who require supplementation

Exclusion Criteria

Anticipated change in primary caregiver (person providing the feed) prior to 4 months

Refusal to consent to donor milk

Enrollment in any other clinical study affecting nutritional management during the feeding intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive either donor milk or formula supplementation during their initial hospital stay

From birth to 72 hours after delivery or until discharge

In-hospital stay

Follow-up

Participants are monitored for health outcomes and breastfeeding efficacy at 1, 2, 3, and 4 months

4 months

Monthly phone calls and a virtual or in-person assessment at 4 months

Exploratory Assessments

Exploratory outcomes include assessments of infant temperament, parental mental health, and milk cortisol concentrations at 2 and 4 months

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Formula
• Human donor milk

Trial Overview The CanDo Trial compares the effects of donor breast milk versus formula on breastfeeding success and infant health outcomes up to 4 months old. Infants will be randomly placed into two groups: one receiving pasteurized donor milk, the other standard formula.

How Is the Trial Designed?

Group I: Human Donor Milk Experimental Treatment 1 Intervention

All infants in this group will receive pasteurized donor milk from Rogers Hixon Ontario Human Milk Bank if they need extra feeding.

Group II: Formula supplement Active Control 1 Intervention

All infants in this group will receive formula which is the standard of care if they need extra feeding.

Formula is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Infant Formula for:

• Nutritional support for infants

Approved in United States as Baby Formula for:

• Nutritional support for infants
• Supplementation for breastfeeding

Approved in Canada as Infant Formula for:

• Nutritional support for infants
• Supplementation for breastfeeding in well-baby units

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Published Research Related to This Trial

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]

In a study involving 363 very low-birth-weight infants, the use of nutrient-enriched donor milk as a supplement to mother's milk did not show significant improvements in neurodevelopmental outcomes compared to preterm formula at 18 months of age.

There were no notable differences in cognitive, language, or motor skills scores between the donor milk and formula groups, indicating that donor milk may not be a necessary treatment goal in settings where mother's milk is adequately provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial. O'Connor, DL., Gibbins, S., Kiss, A., et al.[2022]

Donor human milk is recommended by the World Health Organization for infant feeding when mother's milk is unavailable, and it has been shown to improve health outcomes in low birthweight infants by reducing serious conditions like necrotising enterocolitis and late onset sepsis.

In a series of seven case studies involving orphaned and abandoned children, many HIV exposed or positive, the use of pasteurized donor human milk showed potential protective effects against failure to thrive, diarrhea, atopic dermatitis, and opportunistic infections, despite limited medical records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. Reimers, P., Shenker, N., Weaver, G., et al.[2023]

In a study of 60 healthy term newborns experiencing weight loss, early limited-volume supplementation with pasteurized donor human milk (DHM) did not significantly improve breastfeeding outcomes compared to exclusive breastfeeding.

At 3 months, there was no notable difference in breastfeeding rates or formula use between the DHM group and the exclusive breastfeeding group, suggesting that DHM supplementation may not enhance breastfeeding success in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Kair, LR., Flaherman, VJ., Colaizy, TT.[2020]

Providing donor breastmilk to low birth weight infants in a resource-limited Neonatal Prem Unit is feasible, with 40 out of 95 eligible infants receiving it during the study.

The study found no bacterial contamination or adverse events associated with the use of donor breastmilk, suggesting it can safely prevent complications like necrotizing enterocolitis (NEC) compared to formula feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of setting up a donor breastmilk bank in a neonatal prem unit in a resource limited setting: An observational, longitudinal cohort study. Coutsoudis, I., Adhikari, M., Nair, N., et al.[2022]

High hydrostatic pressure (HHP) pasteurization preserves more nutrients and bioactive components in donor milk compared to traditional Holder pasteurization and flash-heating, making it a potentially better option for very-low-birth-weight infants.

While all pasteurization methods effectively reduced bacterial counts in donor milk, HHP maintained higher levels of important nutrients like folate and lactoferrin, suggesting it could improve the nutritional status of infants fed with donor milk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Hydrostatic Pressure Processing Better Preserves the Nutrient and Bioactive Compound Composition of Human Donor Milk. Pitino, MA., Unger, S., Doyen, A., et al.[2023]

Donor human milk can provide therapeutic benefits to infants, but its use should be based on a careful assessment of the benefits versus known risks, which can vary based on donor selection and processing methods.

High ethical standards are essential in the collection and use of donor human milk to ensure the safety of both donors and recipients, and any supplementation should be done cautiously to avoid interfering with maternal breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. Hartmann, BT.[2020]

A survey of 302 US level 3 NICU directors revealed that 42% reported using pasteurized human donor milk (DM), with larger NICUs and those located in the Midwest and West more likely to utilize it.

Barriers to DM use included uncertainty about ordering processes and guidelines, particularly among non-users, indicating that improving knowledge about DM accessibility and safety could enhance its adoption in NICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pasteurized human donor milk use among US level 3 neonatal intensive care units. Parker, MG., Barrero-Castillero, A., Corwin, BK., et al.[2021]

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]

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11064102/

Unlocking the Potential: A Systematic Literature Review on ... It helps prevent substantial preterm complications, especially necrotizing enterocolitis, bronchopulmonary dysplasia, and late-onset sepsis, ...

2. publications.aap.org publications.aap.org/hospitalpediatrics/article/15/7/616/202055/Examination-of-Donor-Human-Milk-Practices-Within

Examination of Donor Human Milk Practices Within Well ... The aim of this study was to evaluate access to pasteurized donor human milk (PDHM) among neonatal intensive care units (NICUs) and well newborn nurseries ...

3. milkbankne.org milkbankne.org/current-research-on-donor-milk/

Current Research on Donor Milk Compared to their formula-fed counterparts, extremely preterm infants fed donated human milk had half the rate of necrotizing enterocolitis, a common life- ...

4. nature.com nature.com/articles/s41390-024-03309-x

Donor human milk versus infant formula for low-risk infants We identified 11 relevant studies reporting on supplementation of mothers' own milk (MOM) with donor human milk (DHM) compared to infant formula ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0378378223001767

Outcomes in very preterm infants receiving an exclusive ... This study compared unfortified pasteurised human donor milk and formula supplements. The principal outcome was survival to 34w postmenstrual age without ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7202855/

Maintaining safety and service provision in human milk banking Human milk banks screen and recruit donors, and have wide-ranging precautions to ensure the safety of donor milk.

8. fda.gov fda.gov/science-research/pediatrics/use-donor-human-milk

Use of Donor Human Milk Risks for the baby include exposure to infectious diseases, including HIV, to chemical contaminants, such as some illegal drugs, and to a ...

9. nature.com nature.com/articles/s41390-023-03004-3

the hazards of a commercial human milk industry The rise of a commercial human milk industry raises medical practice, health services, patient safety, and ethical concerns, and may prove as hazardous to ...