Cerebral Intraventricular Hemorrhage

New Study Exposes Bovine Fortification Protocol Is Hurdle to Advancing the Standard of Care, Questions Feasibility of Randomized Controlled Trials in Vulnerable Premature Infant Population DUARTE, Calif., Feb. 6, 2024 /PRNewswire/ -- Optimizing nutrition for premature infants remains an important focus in neonatal care. More than 20 peer-reviewed studies of 5,000+ preterm infants demonstrated that, compared to bovine milk-based fortifiers (BMBF), Prolacta Bioscience's human milk-based fortifiers (HMBF) improve growth and development1-7 and provide clinically significant reductions in comorbidities.1,2,8-20 The health benefits from the use of HMBF have also shown significant annual cost savings for hospitals.8 More than 100,000 critically ill and preterm infants have received Prolacta's human milk-based nutritional products.21 Prolacta's Exclusive Human Milk Diet (EHMD) Protocol, introduced in 2022, is based on data showing that hospitals with the best outcomes start fortification as early as day one and advance feeds quickly.1,7,22 Yet, in contrast to this protocol and more than a decade of extensive clinical evidence, two small randomized controlled trials (RCTs) — Jensen with 228 infants and O'Connor with 127 infants — found no statistically significant difference in mortality and morbidity when comparing HMBF to BMBF. While the RCTs were intended to provide a head-to-head comparison between fortifier products, the feeding protocols fundamentally differed. HMBF recommendations for best outcomes regarding the day fortification should begin and the speed at which feeds are advanced were not followed in either study. Both RCTs were designed more than six years ago with fortification protocols intended to mitigate the risks of BMBF, which is known to cause feeding intolerance and severe complications in preterm infants, including sepsis and necrotizing enterocolitis (NEC), a leading cause of preemie death.23 Ethical Boundaries Limit RCT Feasibility The ability to fortify early and advance feeds quickly with HMBF raises an important ethical issue for RCT design. The known risks of BMBF established the decades-old standard of care in the neonatal intensive care unit (NICU) to delay fortification until preterm infants can tolerate the risks of the foreign protein. Given these known risks, randomizing extremely premature infants to day-one fortification with BMBF would unjustly endanger this vulnerable patient population. In seeking to mitigate BMBF's risk, the protocols used in the RCTs demonstrated severely delayed EHMD implementation, thus reducing the observable EHMD benefits. Yet, despite feeding protocols that were incongruent with established EHMD guidelines, both the RCTs showed lower morbidity and mortality rates for infants in the HMBF arms, which are clinically significant findings: While significantly underpowered, the Jensen study showed the HMBF death rate was 47% lower than BMBF.24 After adjusting for gestational age, the HMBF group in the Jensen study had decreased odds of bronchopulmonary dysplasia (BPD) at 36 weeks (p = 0.049).24 The O'Connor study demonstrated a 50% reduction in late-onset sepsis and a statistically significant reduction in retinopathy of prematurity (ROP) in infants receiving HMBF.13 "As clinicians, we must review studies with a critical lens and truly consider the body of evidence on topics critical to the well-being of our patients," said Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. "I am convinced about the advantages of HMBF for critically ill and premature babies because I witnessed the impact with my own patients in Baltimore. What began as an initiative to decrease the incidence of NEC in our unit quickly became a unit-wide initiative to provide a clearly superior standard of care." Real-World Evidence Demonstrates Improved Outcomes and Reduced Costs Extensive real-world data affirm EHMD adoption enables critical health improvements for premature infants and major cost reductions for hospitals. Analysis of 2019-2022 data from 3,000+ patients at 60+ U.S. hospitals found EHMD implementation improved health outcomes and reduced costs, generating a 2.6X dollar-for-dollar return on investment.25 Similarly, a 2023 peer-reviewed report found EHMD implementation resulted in annual cost savings of $500,000 to $3.4 million per hospital from a reduction in comorbidities and shorter lengths of stay among very low birth weight infants.8 The body of real-world evidence in support of HMBF is substantial. It has been clinically proven in more than 20 peer-reviewed clinical studies that compared to BMBF, HMBF when used as part of an Exclusive Human Milk Diet demonstrated: Lower mortality and morbidity14,16,19 Reduced incidence of feeding intolerance15 Achieved adequate growth1,2,7 Reduced incidence of BPD1,12,14,15 Reduced incidence of ROP12,14,15 Reduced late-onset sepsis incidence and evaluations12-14 Reduced risk of NEC14,15,20 Improved long-term outcomes such as neurodevelopment4,5 Shortened stays in the NICU15 Reduced hospital costs8,15,25,26 Achieved better growth in term infants recovering from surgery for single ventricle physiology (SVP)27 and congenital gastrointestinal disorders (CGIDs)28 About Prolacta Bioscience Prolacta Bioscience® is a global life sciences company dedicated to Advancing the Science of Human Milk® to improve health outcomes for critically ill and premature infants. More than 100,00021 extremely premature infants worldwide have benefited from Prolacta's human milk-based products, which have been evaluated in more than 20 peer-reviewed clinical studies. Hospitals adopting Prolacta's Exclusive Human Milk Diet realize a 2.6X return on investment.25 Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity. Learn more at , on X, Instagram, Facebook, and LinkedIn. Media Contact: Loren Kosmont [email protected] 310-721-9444 References 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 Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054 Gates A, Thompson AB, Marin T, Waller JL, Patel J, Stansfield BK. Novel multinutrient human milk-based human milk fortifier promotes growth and tolerance in premature infants. J Parenter Enteral Nutr. 2022;46(4):817-827. doi:10.1002/jpen.2249 Bergner EM, Shypailo R, Visuthranukul C, et al. Growth, body composition, and neurodevelopmental outcomes at 2 years among preterm infants fed an exclusive human milk diet in the neonatal intensive care unit: a pilot study. Breastfeed Med. 2020. 15(5):304-311. doi:10.1089/bfm.2019.0210 Rahman A, Kase J, Murray Y, et al. Neurodevelopmental outcome of extremely low birth weight infants fed an exclusive human milk diet is not affected by growth velocity. Breastfeed Med. 2020;15(6):362-369. doi:10.1089/bfm.2019.0214 Sandhu A, Fast S, Bonnar K, Baier RJ, Narvey M. Human-based human milk fortifier as rescue therapy in very low birth weight infants demonstrating intolerance to bovine-based human milk fortifier. Breastfeed Med. 2017;12(9):570-573. doi:10.1089/bfm.2017.0017 Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants ≤ 1250 grams birth weight. BMC Res Notes. 2013;6:459. Published 2013 Nov 13. doi:10.1186/1756-0500-6-459 Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs. BMC Pediatr. 2023;23(1). doi.org/10.1186/s12887-023-04047-5 Osmanova M, Müller MJ, Habisch B, Hippe A, Seeliger S. Nutrition of infants with very low birth weight using human and bovine based milk fortifier: benefits and costs. Neonat Pediatr Med. 2021;S10:003. Hanford J, Mannebach K, Ohler A, Patten M, Pardalos J. Rates of comorbidities in very low birth weight infants fed an exclusive human milk diet versus a bovine supplemented diet. Breastfeed Med. 2021;16(10):814-820. doi:10.1089/bfm.2020.0345 Carome K, Rahman A, Parvez B. Exclusive human milk diet reduces incidence of severe intraventricular hemorrhage in extremely low birth weight infants. J Perinatol. 2021;41(3):535-543. doi:10.1038/s41372-020-00834-5 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 O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial [published correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears in Am J Clin Nutr. 2020 May 1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067 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 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134 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 Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024 Herrmann K, Carroll K. An exclusively human milk diet reduces necrotizing enterocolitis. Breastfeed Med. 2014;9(4):184-190. doi:10.1089/bfm.2013.0121 Huston RK, Markell AM, McCulley EA, et al. Decreasing necrotizing enterocolitis and gastrointestinal bleeding in the neonatal intensive care unit: the role of donor human milk and exclusive human milk diets in infants ≤1500 g birth weight. Infant Child Adolesc Nutr. 2014;6(2):86-93. doi:10.1177/1941406413519267 Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595.e1. doi:10.1016/j.jpeds.2013.07.011 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):562-7.e1. doi:10.1016/j.jpeds.2009.10.040 Data on file; estimated number of infants fed Prolacta's products from January 2007 to August 2023. Salas AA, Gunawan E, Nguyen K, et al. Early human milk fortification in infants born extremely preterm: a randomized trial. Pediatrics. 2023;152(3):e2023061603. doi:10.1542/peds.2023-061603 Ginglen JG, Butki N. Necrotizing Enterocolitis. StatPearls Publishing [Internet]. 2023. Available from: Jensen GB, Domellöf M, Ahlsson F, Elfvin A, Navér L, Abrahamsson T. Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial. eClinicalMedicine. 2023. . 1016/j.eclinm.2023. 102375 Data on file; hospital-provided outcomes analysis from 2019 to 2022. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002 Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N, Pruetz JD, Costello JM, Cooper DS, & Cardiac Neonate Nutrition Study Group. A randomized trial of an exclusive human milk diet in neonates with single ventricle physiology. J Pediatr. 2022;256: 105–112. doi.org/10.1016/j.jpeds.2022.11.043 Karpen, H. Impact of an exclusive human milk diet in neonates with congenital gastrointestinal disorders: initial clinical results. Oral presentation at ISHMSI, Vienna, 2022 available at: SOURCE Prolacta Bioscience

ORANGE, Calif, Aug. 2, 2023 /PRNewswire/ -- According to a review paper published in a recent issue (Aug. 3, 2023) of the New England Journal of Medicine (NEJM), preterm babies face a high risk of long-term neurological and developmental disabilities, despite health care advances that are keeping them and very preterm infants alive. Dr. Terrie Inder, an expert on the newborn brain and director of the Center for Neonatal Research at Children's Hospital of Orange County (CHOC), is the lead author of "Defining the Neurological Consequences of Preterm Birth." The paper provides a comprehensive study of what is known about neurological consequences of preterm birth, as well as recognizes the gaps. Dr. Inder wrote the 10-page paper, which has 93 research citations, with Dr. Joseph J. Volpe, a founder of neonatal neurology with his seminal book, Neurology of the Newborn, and Peter J. Anderson, Ph.D., who is affiliated with Boston Children's Hospital. Globally, an estimated 15 million infants are born preterm (less than 37 weeks' gestation). Dr. Inder's paper focuses on brain injuries and long-term adverse neurologic effects of preterm babies and very preterm babies (those born between 32 weeks and 26 weeks). Because their brains have yet to mature, these infants are vulnerable to three types of brain injuries: those affecting the white matter, germinal matric-intraventricular hemorrhage, and cerebellar hemorrhage. "We know these brain injuries occur commonly, although they are often unrecognized without magnetic resonance imaging (MRI) scans of the infant's brain," said Dr. Inder. "We're still working on preventative strategies and remediating these injuries from having adverse neurological outcomes in later life through rehabilitation." In addition to these three injuries, a preterm infant's time spent in the neonatal intensive care unit (NICU) can influence brain development with neurological consequences – for example, being cared for in an environment with lights, noises, and smells. Other important factors include nutrition and nurturing, such as parent voice and touch/holding. There are also influences after discharge such as rehabilitation therapies and family care. Dr. Inder's paper will pave the way for future studies on brain injuries, helping experts develop strategies to improve long-term neurological outcomes in the preterm infant. Dr. Inder is considered one of the world's leading experts on neonatal brain injury. She has spent the better part of her career looking at MRIs to track the development of injuries and how the brain develops in preterm infants. To speak to her about her paper in NEJM, contact [email protected]. About CHOC: Children's Hospital of Orange County (CHOC), a nationally recognized pediatric healthcare system based in Orange County, California, is committed to being a leading destination for children's health by providing exceptional and innovative care. CHOC's community includes two state-of-the-art hospitals in Orange and Mission Viejo and a regional network of primary and specialty care clinics serving children and families across four counties. CHOC offers several clinical programs of excellence providing the highest levels of care for the most serious pediatric illnesses and injuries, physical and mental. CHOC's research and innovation institutes are focused on translating real patient needs into real-world treatments so every child can live the healthiest and happiest life possible. MEDIA CONTACT: [email protected] SOURCE CHOC

The 22nd European Congress of Neurosurgery will take place in Belgrade, Serbia, on October 16-20, 2022. Dr. Behnam Rezai Jahromi, a neurosurgeon from Helsinki University Hospital, will present a case series poster, titled "Active CSF Exchange System for IVH Treatment." Dr. Rezai Jahromi will also lead a live IRRAflow educational session on Tuesday, October 18th, at 1000 CET within the IRRAS booth in the Congress' Exhibit Hall. STOCKHOLM, Oct. 13, 2022 /PRNewswire/ -- IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced it will be exhibiting at EANS 2022, the 22nd European Congress of Neurosurgery, hosted by the European Association of Neurological Societies. After two consecutive years in which the Congress was impacted by the Covid-19 pandemic, the EANS Annual Congress is again being held in person in Belgrade, Serbia, on 16 to 20 October 2022. Attendees of EANS 2022 are encouraged to learn more about IRRAS' products, including its IRRAflow Active Fluid Exchange system, by visiting IRRAS' booth #10. In addition to exhibiting its products for conference participants, clinical data regarding the use of the IRRAflow system to treat intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) will be presented in a case series poster by Dr. Behnam Rezai Jahromi, a neurosurgeon from Helsinki University Hospital. The poster presentation, titled "Active CSF Exchange System for IVH Treatment," will be available for review, in-person and virtually, for registered participants of EANS. "My experience utilizing IRRAflow has shown impressive results in clearing out toxic blood in ventricles after patients have experienced ruptured aneurysms and the associated intracranial hemorrhage," said Dr. Rezai Jahromi. "The combination of the IRRAflow system's recurring irrigation, when combined with thrombolytic medication, can change the composition of cerebrospinal fluid, accelerate the ability to remove the toxic materials, and improve the clinical outcomes of these critically ill patients." Dr. Rezai Jahromi will also lead an educational session on Tuesday, October 18th, at 1000 CET within the IRRAS booth. During the session, Dr. Rezai Jahromi will present his clinical experience utilizing IRRAflow to treat IVH patients and will also provide an update on the ARCH ( Active Removal of Intra cerebral Hematoma via active irrigation of ventricular system) clinical trial. To learn more about the ARCH clinical trial, click here: . About IRRAS IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners. IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit . IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS). For more information, please contact: Sten Gustafsson Director, Investor Relations [email protected] +46 102 11 5172 The information was released for public disclosure, through the agency of the contact person above, on October 13, 2022, at 8:30 (CET). SOURCE IRRAS