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Prolacta Bioscience introduces its first evidence-based feeding protocol for an exclusive human milk diet in the NICU

Nutritional Guidance Sets Premature Infants on Track for Healthy Growth and Improved Outcomes

DUARTE, Calif., June 14, 2022 — Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced the introduction of the first evidence-based feeding protocol for the use of an Exclusive Human Milk Diet including Prolacta’s products (Prolacta’s EHMD) in the neonatal intensive care unit (NICU). Prolacta’s EHMD ProtocolTM addresses the nutritional risks of late and inadequate nutrition facing low birth weight premature infants and is the first nutritional guidance issued for the use of the company’s human milk-based nutritional products.

Developed in conjunction with independent clinicians, registered dieticians, nurses, and neonatologists, Prolacta’s EHMD Protocol is backed by 15 years of clinical experience and more than 20 clinical studies.1 The protocol presents additional perspective on the standard of care in NICUs that can help premature infants avoid complications and reach key growth goals.

“This protocol provides best-practice guidance to members of the NICU team as we tailor nutrition to each infant’s needs and risk factors,” said Rangasamy Ramanathan, MD, professor of pediatrics, division chief, Division of Neonatal Medicine, LAC+USC Medical Center. “A standardized feeding approach for an EHMD with human milk-based products helps eliminate the uncertainty in meeting infants’ protein goals to achieve adequate growth with fewer complications.”

Prolacta’s EHMD Protocol guides decision-making in the NICU as clinicians work to:

  • Achieve healthier growth with fewer complications
  • Fortify safely and confidently in the first week of life
  • Tailor nutrition to each infant's individual needs and risk factors
  • Account for variability of mother's own milk/unanalyzed donor milk
  • Supplement for fat loss tubing
  • Meet protein goals while staying on-label

Prolacta’s EHMD Protocol supports clinicians in delivering the optimal nutrients to fragile infants at the optimal time — helping as they work to achieve better health outcomes,2,3,4 lower hospital costs,5,6 and significantly reduce the risk of complications and feeding intolerance associated with cow milk-based fortifiers.2,3,4,5,7,8,9

Over the past 15 years, more than 20 clinical studies involving more than 5,000 premature infants have shown that hospitals with the best outcomes followed similar feeding practices with the use of Prolacta’s fortifiers.1 Inversely, it is proven that delayed fortification leads to less-optimal results in critically ill, premature infants.10

An EHMD is achieved when 100% of the protein, fat, and carbohydrate in an infant’s diet are derived from human milk. An EHMD with Prolacta’s 100% human milk-based fortifiers, compared with the use of cow milk-based fortifiers or formula, is known to reduce the risk of severe complications and feeding intolerance in preterm infants.7

Fortify Early for the Best Outcomes

For years, the risks associated with cow milk-based fortifiers left healthcare professionals in the NICU cautious about starting fortification too early. With Prolacta’s EHMD Protocol, clinicians can safely begin fortification as early as the first week of an infant’s life, confident that issues such as feeding intolerance and other complications have been shown to be significantly reduced.2,3,5,11

“Prolacta’s EHMD Protocol can reduce the incidence of comorbidities, support adequate growth, and improve mortality rates, offering groundbreaking benefits for this fragile patient population,” said Melinda Elliott, MD, FAAP, and chief medical officer at Prolacta. “Even the most vulnerable infants born weighing less than 750 g have been shown to greatly benefit from an EHMD, giving them the best chance for a healthy, bright future.”2,3,4,5,7,8,9,11,12,13,14,15

Proven Safety; Flexible Feeding Advancement

To help meet each patient’s unique needs, Prolacta’s EHMD Protocol is designed to provide flexible feeding advancement based on each premature infant’s weight, clinical status, and health risk factors.

Improved Short- and Long-Term Outcomes

Prolacta’s EHMD Protocol supports adequate growth with fewer complications as measured by increases in length, head circumference, and weight.11 These gains lower the risk of long-term metabolic morbidities including obesity, diabetes, and cardiovascular disease.16 Research has shown that Prolacta’s fortifiers, when used as part of an EHMD, support healthy body composition with improvements in lean body mass, normal total body fat, and adequate bone mineralization.16 Furthermore, for premature infants fed an EHMD, the benefits of appropriate nutrition extend to long-term neurocognitive development.14

Compared to cow milk-based fortifiers, an EHMD with Prolacta’s 100% human milk-based nutritional fortifiers has been clinically proven in more than 20 peer-reviewed clinical studies to:

  • Lower mortality and morbidity3,5,8,17
  • Reduce incidence of feeding intolerance3,5
  • Achieve adequate growth2,11,17
  • Reduce incidence of bronchopulmonary dysplasia (BPD)2,4,5,8
  • Reduce incidence of retinopathy of prematurity (ROP)3,5,8
  • Reduce late-onset sepsis incidence and evaluations8
  • Reduce risk of necrotizing enterocolitis (NEC)3,5,7,8,18
  • Improve long-term outcomes such as neurodevelopment14,19
  • Shorten stays in the NICU5
  • Reduce hospital costs5,6

For a copy of Prolacta’s EHMD Protocol, email

About Human Milk-Based Products

The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membranes, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products.20 Bioactivity is thought to support infants’ immunity, development, growth, and long-term health.21

Prolacta’s 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.1 Prolacta’s nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.1 Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.22,23

About Prolacta Bioscience

Prolacta Bioscience® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of critically ill, premature infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals. More than 80,000 premature infants have benefited from Prolacta’s nutritional products worldwide to date.* Established in 1999, Prolacta is the world’s leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry’s strictest quality and safety standards for screening, testing, and processing human donor milk. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found on Twitter, Instagram, Facebook, and LinkedIn.

*Estimated number of premature infants fed Prolacta’s products from January 2007 to December 2021; data on file.

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Media Contact:
Loren Kosmont


  1. Data on file.
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