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Prolacta Bioscience announces that results of the double-blind study published in the Journal of Pediatrics demonstrate that extremely premature infants who are fed an exclusive human milk diet instead of preterm formula have a significantly lower incidence of surgery associated with the intestinal disease necrotizing enterocolitis (NEC) and require fewer days of intravenous feedings through total parenteral nutrition (TPN).
The objective of the study was to compare the duration of TPN, morbidities, and growth patterns in extremely premature infants fed exclusive diets of either bovine milk - based preterm formula or donor human milk and human milk-based human milk fortifier (HMF). The trial was a clear comparison of the effects of formula versus donor human milk. The trial's conclusion supported the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit. The study's lead author is Elizabeth A. Cristofalo, MD, MPH with Johns Hopkins School of Medicine in Baltimore, MD.
"These results are not surprising," said Scott Elster, CEO of Prolacta Bioscience. "They simply reinforce the results of the previous randomized clinical trial and the experience of our customers. There are approximately 40,000 babies born each year weighing less than 2 lbs 12 ounces. These babies would fit in the palm of your hand. They are fed through a tube and spend the first 70-90 days of their life in the neonatal intensive care unit. These babies should be fed an exclusive human milk diet and this study clearly demonstrates that fact."
The study, which can be found online, reinforces the landmark Sullivan study published in 2009 in the Journal of Pediatrics, which concluded that for very low-birth-weight preterm infants weighing less than 1250 grams, an exclusively human milk-based diet was associated with significantly lower rates of NEC and surgical NEC, when compared to very low-birth-weight preterm infants who received a diet that included cow milk-based products.
Prolacta is setting the new standard of safety and quality in human milk processing, with a pharmaceutical grade manufacturing facility that is the first and only of its kind worldwide. Additionally, Prolacta is the only organization that includes a safety combination of DNA matching of mom to milk, testing for drugs and other contamination, as well as HIV-1, HCV, and HBV through PCR testing to ensure the highest-quality available human milk products to feed the sickest infants in hospital NICUs. Prolacta's advanced technology provides for an unmatched margin of safety to protect from potential transmission of virus.
Authors: Elizabeth A. Cristofalo, MD, MPH, Richard J. Schanler, MD, Cynthia L. Blanco, MD, Sandra Sullivan, MD, Rudolf Trawoeger, MD, Ursula Kiechl-Kohlendorfer, MD, MSc, Golde Dudell, MD, David J. Rechtman, MD, Martin L. Lee, PhD, Alan Lucas, MD, Steven Abrams
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Bioscience, Prolacta. "Prolacta study published in Journal of Pediatrics demonstrates lower incidence of intestinal disease in preemies fed exclusive human milk diet." Medical News Today. MediLexicon, Intl., 2 Sep. 2013. Web.
4 Dec. 2013. <http://www.medicalnewstoday.com/releases/265491>
Bioscience, P. (2013, September 2). "Prolacta study published in Journal of Pediatrics demonstrates lower incidence of intestinal disease in preemies fed exclusive human milk diet." Medical News Today. Retrieved from
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