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Head-to-head subgroup analysis of human milk–based fortifiers finds significant improvements in health and brain growth measure for preemies fed mother’s milk plus Prolacta’s fortifiers

Subgroup Analysis of a Seminal Study Published in April 2020 Journal of Breastfeeding Medicine

DUARTE, Calif., May 12, 2020 – Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk–based nutritional products, announced today that a subgroup analysis of a randomized, multicenter clinical study demonstrated a fivefold reduced risk of certain serious complications and death, and greater increases in head circumference, which suggests better brain growth, using Prolacta’s 100% human milk–based fortifier in place of cow milk–based fortifier among preterm infants. All study infants were fed only their mother’s milk, in addition to either human- or cow-milk-based fortifiers and were treated in a neonatal intensive care unit (NICU).1

The analysis was conducted to more closely compare feeding protocols used in NICUs today and represents one of the only studies of preterm infant feeding protocols ever to directly compare fortifiers made from either human milk or cow milk among infants whose only other source of enteral nutrition is milk from their mothers.

The study, “Preterm Infants Fed Cow's Milk–Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk,” was published in Breastfeeding Medicine on April 2, 2020, and found the following health outcomes among preterm infants who received Prolacta’s 100% human milk–based fortifiers:

“Those fed the human milk–derived fortifier were significantly advantaged in terms of a reduced incidence of morbidity,” wrote the study authors, who were led by Alan Lucas, MD, Professor at the Institute of Child Health, University College London in the United Kingdom.1

Many studies, including the original study2 from which this analysis was derived, compared human- and cow-milk-based fortifiers in infants fed various combinations of human milk (from either their mother or donors) and cow milk–based preterm formula. However, many healthcare professionals prefer direct clinical comparison for the specific effects of a 100% human milk–based fortifier vs a cow milk–based fortifier, since avoidance of exposure to cow-milk proteins is one likely reason 100% human milk–based fortifiers are so beneficial.

Based closely on the methods by which preterm infants are currently being fed in NICUs worldwide, the subgroup analysis focused specifically on the 114 infants who received their mother’s milk plus either:

“The original Sullivan study has been criticized for not representing current NICU feeding practices which prioritize mother’s milk or donor human milk over cow milk–based preterm formula. The Lucas subgroup analysis removed that variable to provide a head-to-head comparison of human- vs cow-milk-based fortifiers mixed with a base of mother’s milk. It demonstrated, with statistical significance, that the cow-milk-based fortifiers alone lead to adverse outcomes, while preterm infants fed Prolacta’s human milk–based fortifier achieved the same positive results including fewer complications as demonstrated in the original study. This subgroup analysis also found additional improvements in head growth, which is an indirect measure of brain growth, in the infants receiving Prolacta’s fortifier,” said Melinda Elliott, MD, Chief Medical Officer, Prolacta Bioscience.

About Prolacta Bioscience
Prolacta Bioscience®, Inc is a privately held life sciences company dedicated to Advancing the Science of Human Milk®. Prolacta is the world’s leading hospital provider of 100% human milk–based nutritional products, which have reduced complications and improved the health of more than 63,000 extremely premature infants globally. Prolacta is also exploring the therapeutic potential of human milk across a wide spectrum of human diseases including applications for infants requiring surgery for congenital cardiac and gastrointestinal disorders. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta leads the industry with the highest quality and safety standards for the screening and testing of donor milk. Prolacta is a global company with headquarters in Duarte, California, and can be found online at, on Twitter at @prolacta, on Instagram at @prolacta_bioscience, on Facebook at, and on LinkedIn at

Media Contact:
Loren Kosmont


  1. Lucas A, Boscardin J, Abrams SA. Preterm infants fed cow’s milk-derived fortifier had adverse outcomes despite a base diet of only mother’s own milk. Breastfeed Med. 2020. [Epub ahead of print]. doi:10.1089/bfm.2019.0133
  2. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567. doi:10.1016/j.jpeds.2009.10.040