Prolacta Bioscience fortifiers reduce risk of serious lung disease and hospital costs among premature infants, compared to cow milk-based fortifiers

Four Studies That Used Prolacta’s 100% Human Milk-Based Fortifiers as Part of an Exclusive Human Milk Diet in the NICU Show Reduced Rates of Bronchopulmonary Dysplasia (BPD), Associated Hospital Costs, and Rehospitalizations

DUARTE, Calif., November 10, 2020 – Four clinical studies found significant benefits for lung health when Prolacta Bioscience^® 100% human milk-based nutritional fortifiers were used to nourish extremely preterm infants in the neonatal intensive care unit (NICU). Nutritional fortifiers are necessary for extremely premature infants because mother’s own milk or donor breastmilk alone cannot provide the required levels of protein and calories needed for growth.

In three recent studies, the use of Prolacta’s fortifiers as part of an exclusive human milk diet (EHMD)¹ led to statistically significant decreases (weighted average of 9.7%) in the serious lung disease bronchopulmonary dysplasia (BPD) among premature infants compared to those fed cow milk-based fortifiers.^{2, 3, 4} A fourth study demonstrated that time is of the essence. Premature infants who received Prolacta’s fortifiers in the first days of life as part of an EHMD experienced a 15% reduction in the incidence of BPD, compared to later administration of the 100% human milk-based fortifiers.⁵

Hospital NICUs nationwide are working hard to lower rates of BPD. One promising approach to reducing the incidence of BPD is to replace cow milk-based fortifiers with Prolacta’s 100% human milk-based fortifiers when supplementing feeds in the first days of life for extremely premature infants. Prolacta’s fortifiers are clinically proven to deliver the concentrated nutrition premature infants need to promote proper growth and development, in a format that is safe and well-tolerated, as compared to cow milk-based fortifiers.

“Four different studies showed that a NICU feeding protocol that includes Prolacta’s fortifiers helped reduce the incidence of BPD and associated healthcare costs,” said Melinda Elliott, M.D., FAAP, and chief medical officer of Prolacta. “Reducing BPD in premature infant populations has significant long-term benefits and lifelong impacts on a child’s lung health and neurological development, which positively impacts not only the infants, but their families, communities, and the health system as a whole.”

Clinical Evidence

▪ A study published in the journal Neonatal Perinatal Medicine demonstrated that adding Prolacta’s 100% human milk-based fortifiers to feeds in the first days of life results in improved growth velocities for weight and head circumference and a 15% reduction (P = 0.008) in the incidence of BPD/chronic lung disease (CLD) among premature infants born weighing ≤ 1,250  g, compared with those who received late fortification.⁵ These benefits were seen without an increase in complications.

▪ In a study where clinical outcomes were the primary outcome measure, the University of Virginia NICU compared the use of Prolacta’s 100% human milk-based fortifiers to cow milk-based fortifiers among 205 premature infants being fed mother’s own or donor human milk. Those in the Prolacta fortifier group showed a 16.5% decrease in incidence of BPD (48.5%, compared with 65%; P = 0.018).²

▪ Two additional studies where BPD was a secondary outcome showed reduced incidence of BPD with the use of Prolacta’s fortifiers. These studies compared premature infants receiving an EHMD (human milk combined with Prolacta’s fortifiers) versus those receiving various combinations of human milk with cow milk-based formula and/or fortifiers. Once again, for infants receiving Prolacta’s fortifiers, incidence of BPD was reduced 8.6% (from 56.3% to 47.7%; P = 0.001)³ and 11% (from 26% to 15%; P < 0.001) respectively.⁴

BPD Increases Hospital Stays and Health Care Costs

An infant’s lungs are among the last organs to fully develop inside the womb. BPD is a serious lung condition mostly affecting low birth weight and premature infants. The longer a premature infant receives supplemental oxygen or mechanical ventilation, the higher the risk of developing BPD.⁶ During the first year of life, premature infants diagnosed with BPD have longer hospital stays and higher rehospitalization rates when compared to premature infants without BPD; this translates to a 53% increase in median hospitalization costs.⁷

A BPD diagnosis among preterm infants is also associated with an increased risk of developing lung problems throughout life, such as childhood asthma and chronic obstructive pulmonary disease (COPD) in adulthood.^7,8 Premature infants with severe BPD may be at an increased risk for long-term neurodevelopmental delays in cognition^9,10 and education,^11,12 as well as attention deficit disorder.¹³

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. These life-saving products have reduced complications and improved the health of more than 63,000 extremely premature infants globally.¹⁴ In addition, the company is 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. The company 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 www.prolacta.com, on Twitter @prolacta, on Instagram @prolacta_bioscience, on Facebook at www.facebook.com/prolacta and LinkedIn at www.linkedin.com/company/prolacta-bioscience/.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444

References:

1. An exclusive human milk diet (EHMD) is achieved when 100% of the protein, fat, and carbohydrate in an infant’s diet are derived from human milk. This diet includes Prolacta’s 100% human milk-based fortifiers.
2. Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676
3. Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017;12 (10 ):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
4. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
5. Huston R, Lee M, Rider E, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2020;13(2):215-221. doi:10.3233/NPM-190300
6. Learn about bronchopulmonary dysplasia. American Lung Association. Accessed March 6, 2020. https://www.lung.org/lung-health-diseases/lung-disease-lookup/bronchopulmonary-dysplasia/learn-about-bpd.
7. Lapcharoensap W, Bennett MV, Xu X, Lee HC, Dukhovny D. Hospitalization costs associated with bronchopulmonary dysplasia in the first year of life. J Perinatol. 2020;40(1):130-137. doi:10.1038/s41372-019-0548-x
8. Cheong JLY, Doyle LW. An update on pulmonary and neurodevelopmental outcomes of bronchopulmonary dysplasia. Semin Perinatol. 2018;42(7):478-484. doi:10.1053/j.semperi.2018.09.013
9. Jeng SF, Hsu CH, Tsao PN, et al. Bronchopulmonary dysplasia predicts adverse developmental and clinical outcomes in very-low-birthweight infants. Dev Med Child Neurol. 2008;50(1):51-57. doi:10.1111/j.1469-8749.2007.02011.x
10. Natarajan G, Pappas A, Shankaran S, et al. Outcomes of extremely low birth weight infants with bronchopulmonary dysplasia: impact of the physiologic definition. Early Hum Dev. 2012;88(7):509-515. doi:10.1016/j.earlhumdev.2011.12.013
11. Short EJ, Kirchner HL, Asaad GR, et al. Developmental sequelae in preterm infants having a diagnosis of bronchopulmonary dysplasia: analysis using a severity-based classification system. Arch Pediatr Adolesc Med. 2007; 161(11):1082-1087. doi:10.1001/archpedi.161.11.1082
12. Gray PH, O’ Callaghan MJ, Rogers YM. Psychoeducational outcome at school age of preterm infants with bronchopulmonary dysplasia. J Pediatr Child Health. 2004;40(3):114-120. doi:10.1111/j.1440-1754.2004.00310.x
13. Astbury J, Orgill AA, Bajuk B, Yu VY. Neonatal and neurodevelopmental significance of behaviour in very low birthweight children. Early Hum Dev. 1985;11(2):113-121. doi:10.1016/0378-3782(85)90098-2
14. Data on file; Estimated number of premature infants fed Prolacta’s products from January 2007 to August 2020.