Filling the Supplementation Gap with Donor Human Milk

Every clinician who works with newborns knows that early breast feeding challenges often trigger early supplementation, and early supplementation can pull families away from the breastfeeding goals they started with. 

The problem isn’t a lack of desire to feed human milk, it’s that there isn’t an accessible alternative other than formula.

The trends bear this out. While the vast majority of mothers begin breastfeeding—84% of U.S. infants born in 2022 were ever breastfed, per the CDC Breastfeeding Report Card—continuation rates fall sharply. Among a large nationally representative sample, 60.4% of mothers were still breastfeeding at 3 months, and 54.7% were still breastfeeding at 6 months. Exclusive breastfeeding rates are even lower. And perhaps most telling: research in Pediatrics found 60% of mothers do not breastfeed for as long as they intend to. The gap between intention and outcome points to a systemic problem, not a personal one.

Historically, donor human milk outside of the NICU has been constrained by availability, cost, and limitations of traditional processing. Formula becomes the default because it’s the only option on the shelf. 

A pilot study presented at the International Society for Research in Human Milk and Lactation (ISRHML) 2024 asks what happens when the gap is filled with Gentle-UHT™ processed donor human milk (GHM) instead of formula?  

What follows is a summary of the study’s findings and their implications for future research and clinical practice. We’re featuring this study in LactaLogics’ Clinical Hub because it speaks to the decisions clinicians make every day in newborn and neonatal nutrition. It explored an intervention that seems clinically intuitive, but has been under-studied in an outpatient setting. 

A copy of the original ISRHML 2024 poster is provided at the end of this piece for those who wish to review additional data. 

The study followed breastfed newborns born at 36 weeks or later who were at risk of excessive weight loss at discharge and whose mothers were experiencing insufficient milk volume or a delayed onset of lactogenesis II. These clinical scenarios often trigger early formula supplementation. The patients were healthy, term and late-preterm infants who didn’t meet NICU admission criteria but were vulnerable to early supplementation decisions that can derail breastfeeding. 

All infants received GHM as an alternative to formula. They started supplementation at the mean age of 2.27 days (boys) / 2.47 days (girls), and the mean total duration on GHM was about 5.5 days. 

Among at-risk newborns, GHM supplementation was associated with improved growth velocity after adjustment for chronological age and birth characteristics, with earlier initiation linked to greater gains.

The strongest finding came on day one of supplementation, the model estimated a 0.42% increase in daily growth rate (95% CI [0.018, 0.83]), a statistically significant effect . Seven days of supplementation trended toward a .67% higher average daily growth velocity compared to WHO (World Health Organization) norms that trended negatively (-1.19%) in the same period. While this seven-day projection did not reach statistical significance in this small pilot, the directional consistency across timepoints points to a meaningful clinical signal worth confirming in larger studies. 

Most importantly, 93% of infants maintained an exclusive human milk diet and continued breastfeeding after the study. 

Among at-risk newborns receiving GHM in the first week of life, growth velocity improved compared to a modeled non-supplementation trajectory, earlier initiation was associated with greater weight gain, and 93% of participants maintained exclusive human milk feeding. That’s a clinically meaningful result for a population that has been underserved by the donor milk system. 

The System Behind the Study 

When donor human milk is used in neonatal intensive care, the milk that reaches the baby is very different from the milk that left the breast. Traditional pasteurization methods degrade proteins, alter fats, and change the unique components of breastmilk that support growth and immune protection. Variability in donor milk composition adds another layer of unpredictability.

This pilot study, led by Dr. Robin Hollen at Pediatric Associates in Reno in collaboration with researchers at the University of Nevada Reno School of Medicine and UC Irvine  confronts this reality. 

The donor milk was processed with Gentle-UHT™, a pasteurization method designed to retain more nutrients, and preserve protein, which means the newborns in this study were not receiving the nutritionally diminished donor milk clinicians have historically had to rely on. 

This study challenges the assumption that donor milk is only for preterm infants, as healthy newborns benefited in ways that protected growth and breastfeeding trajectory. It also reframes supplementation as a tool for preserving breastfeeding, and it highlights the role of human milk processing technology in clinical outcomes. 

While this remains a small observational pilot, it points to a meaningful possibility: that bridging at-risk newborns with donor human milk in the critical first days, rather than formula, may help more mothers reach their breastfeeding goals. Donor milk may be one of the tools that helps close the gap between intention and outcome. 

Download the 2024 PAS presentation poster for Impact of Supplementing Donor Human Milk in the First Week of Life: A Pilot Study.

The study, Impact of Supplementing Donor Human Milk in the First Week of Life: A Pilot Study, was presented at the International Society for Research in Human Milk and Lactation (ISRHML) Conference in 2024. The research team disclosed that LactaLogics, Inc. provided the Gentle-UHT™ pasteurized donor human milk used in the study, and that Dr. Rebecca Perry was compensated for her contributions. LactaLogics does not make claims about its products prior to regulatory clearance. Clinical references cite published research and conference presentations.