Prolacta Bioscience, the first and only company to offer human milk fortifier (HMF) made from 100% human breast milk for premature and critically ill infants, has announced the results of a groundbreaking study that will have long-term benefits for the nutritional care of very low-birth-weight preterm infants (less than 2 pounds, 12 ounces or 1250 grams) in the neonatal intensive care unit (NICU). The study was published in The Journal of Pediatrics December 28, 2009 online edition at www.jpeds.com.
“The results of this study are astounding. No other intervention has shown such a beneficial effect for NEC”
The landmark study, whose lead author was Sandra Sullivan M.D. with the department of pediatrics at the University of Florida, Gainesville, concludes that for very low-birth-weight preterm infants weighing less than 1250 grams, an exclusively human milk-based diet is associated with significantly lower rates of necrotizing enterocolitis (NEC) and surgical NEC, when compared to a very low-birth-weight preterm infant who received a diet that includes bovine milk-based products. NEC is a severe complication that often affects preterm infants, in which the intestinal tissue disintegrates. It is a serious disease with a mortality rate approaching 25%. The results of the study are significant because, until recently, the standard of care and the only human milk fortifiers available were bovine-based. This posed challenges for the nutritional care of very low-birth-weight preterm infants in the NICU because of the occurrence of intolerance to feedings, possibly as a result of exposure to non-human protein in the bovine-based fortifier.
“The results of this study are astounding. No other intervention has shown such a beneficial effect for NEC,” said Dr. Sullivan. “Neonatologists now have a way to appropriately nourish very low-birth-weight preterm infants and maintain the benefits of an exclusive human-milk diet. The decision to use traditional bovine-based HMF for these babies should not be made lightly, and warrants reconsideration in all NICUs.”
The trial was comprised of three study groups of infants whose birth weights ranged between 500 and 1250 grams. Groups one and two began fortification at different times. These first two groups of infants received pasteurized donor human milk-based HMF, Prolact+ H2MFTM from Prolacta Bioscience. The third group received the standard feeding protocol of bovine milk-based HMF, and preterm formula if mother’s own milk was not available. The most significant difference among the three study groups was the incidence of NEC, which was approximately two-thirds lower in the two study groups using the human milk-based HMF, compared to the study group using bovine milk-based HMF.
Prolact+ H2MF is the first and only commercially available human milk fortifier made from 100% human breast milk. The current standard practice in the NICU uses bovine milk-based products for human milk fortification. A recent study has demonstrated that for very low-birth-weight preterm infants in the NICU, human breast milk decreases the incidence of diseases such as necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and sepsis. NEC is a devastating disease of the gut and a leading cause of premature infant death.
Prematurity has been escalating steadily over the past two decades, and one out of eight babies is born prematurely in the U.S. Of that category, about 10% of these births are very low-birth-weight preterm infants. Most babies who use Prolacta products are born weighing less than 1250 grams. These infants are considered very low birth weight, and are at substantial risk of serious health problems, lasting disabilities, and even death. Prolacta’s products are formulated to meet specific criteria as prescribed by neonatologists. Therefore, Prolacta standardizes their products with precise calories, nutrients, and proteins to meet these criteria.
Prolacta Bioscience, Inc.