Welcome!

News Feed Item

Prolacta Bioscience(R) Initiates Clinical Trial to Evaluate the Effect of a Specially Fortified Exclusive Human Milk Diet to Improve Growth in Infants Born with Single Ventricle Congenital Heart Defect

DUARTE, CA -- (Marketwired) -- 02/16/17 -- Prolacta Bioscience®, the pioneer in human milk-based neonatal nutritional products, announced today that the first patient has been enrolled in a clinical study to evaluate the effect of a specially fortified exclusive human milk diet (EHMD)(1) to improve growth in infants who have undergone surgery for a serious heart defect known as single ventricle cardiac physiology. Prolacta developed a first-of-its-kind, human milk-based fortifier to address the post-surgical nutrition needs of this fragile infant population.

Single ventricle cardiac physiology occurs in five out of 100,000 live births,(2) and results in a range of clinical problems resulting from the heart having only one adequate ventricle or pumping chamber.(2) The condition is usually fatal unless treated by a series of surgeries.(3) Babies with single ventricle cardiac physiology often have difficulty breathing, feeding and growing.(3,4)

"These medically frail newborns are at high risk for growth failure, due to increased caloric demands due to their heart and pulmonary conditions. This presents unique nutritional challenges," said Principal Investigator Cynthia Blanco, M.D., University of Texas Health Science Center. "We believe a densely fortified human milk diet may be a real benefit to these infants with an ultimate goal of optimizing their nutritional status prior to their second surgery."

"While not preemies, these babies have a similar need for rich nutrition delivered in small volumes," said Scott Elster, CEO of Prolacta. "This study is the first to explore the benefits of human milk-based fortifiers in a population of fragile infants other than preemies. The medical centers will be using a new formulation that we developed specifically for these babies, and we hope that it will make a difference to their health and healing."

The randomized controlled study will evaluate a minimum of 84 infants, starting at age seven days or younger, who require surgery to correct a single ventricle cardiac physiology present at birth, and who were fed an EHMD prior to study enrollment. The study will measure growth rate and clinical outcomes for up to 30 days following surgery in these infants. One group will be fed an EHMD that includes a new formulation of Prolacta's highest caloric density exclusive human milk-based fortifier, while the other group will receive a standard diet that includes some cow milk-based nutrition. The hypothesis is that infants fed the EHMD will have short-term benefits, including improved growth, reduced episodes of feeding intolerance, sepsis and necrotizing enterocolitis (damaged intestinal tissue), reduced stay in the hospital and potentially improved long-term neurodevelopmental outcomes.

The study is titled, "A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants with Single Ventricle Physiology Fed an Exclusive Human Milk Diet with Early Nutritional Fortification Following Surgical Repair." It is expected to take place at 12 centers: University of Texas Health Science Center at San Antonio (lead center), San Antonio, Texas; University of Texas Southwestern Medical Center, Dallas, Texas; Texas Children's Hospital, Houston, Texas; Cook Children's Medical Center, Fort Worth, Texas; Children's Hospital of Philadelphia, Philadelphia, Pa.; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Children's Hospital of Orange County, Orange, Calif.; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.; Columbia University Medical Center, New York, N.Y.; Emory University Hospital, Atlanta, Ga.; University of Oklahoma Health Sciences Center, Oklahoma City, Ok.; and UF Health Shands Children's Hospital, Gainesville, Fla.

About Prolacta Bioscience
Prolacta Bioscience, Inc. is a privately-held life sciences company dedicated to Advancing the Science of Human Milk®. The company pioneered the development of human milk-based neonatal nutritional products to meet the needs of critically ill, premature infants in the NICU. Prolacta leads the industry in the quality and safety of nutritional products made from donor breast milk and operates the first and only pharmaceutical-grade manufacturing facility for the processing of human milk. For more information, please visit www.prolacta.com.

(1) An exclusive human milk diet (EHMD) is when 100 percent of the protein, fat and carbohydrates in an infant's intake are derived solely from human milk.
(2) Adult Congenital Heart Association. "Single Ventricle Defects and the Fontan." Accessed Nov. 13, 2016.
(3) Cadet, J.V., "Children's Hospital of Philadelphia: Treating Single Ventricle Defects." Cardiovascular Business. July 26, 2010. Accessed Nov. 13, 2016.
(4) American Heart Association. "Single Ventricle Defects." Updated Oct. 21, 2015. Accessed Nov. 13, 2016.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to ...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developer...
For financial firms, the cloud is going to increasingly become a crucial part of dealing with customers over the next five years and beyond, particularly with the growing use and acceptance of virtual currencies. There are new data storage paradigms on the horizon that will deliver secure solutions for storing and moving sensitive financial data around the world without touching terrestrial networks. In his session at 20th Cloud Expo, Cliff Beek, President of Cloud Constellation Corporation, ...
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
Interested in leveling up on your Cloud Foundry skills? Join IBM for Cloud Foundry Days on June 7 at Cloud Expo New York at the Javits Center in New York City. Cloud Foundry Days is a free half day educational conference and networking event. Come find out why Cloud Foundry is the industry's fastest-growing and most adopted cloud application platform.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
SYS-CON Events announced today that Carbonite will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Carbonite protects your entire IT footprint with the right level of protection for each workload, ensuring lower costs and dependable solutions with DoubleTake and Evault.
SYS-CON Events announced today that EARP Integration will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. EARP Integration is a passionate software house. Since its inception in 2009 the company successfully delivers smart solutions for cities and factories that start their digital transformation. EARP provides bespoke solutions like, for example, advanced enterprise portals, business intelligence systems an...
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assis...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
In his session at 20th Cloud Expo, Brad Winett, Senior Technologist for DDN Storage, will present several current, end-user environments that are using object storage at scale for cloud deployments including private cloud and cloud providers. Details on the top considerations of features and functions for selecting object storage will be included. Brad will also touch on recent developments in tiering technologies that deliver single solution and an end-user view of data across files and objects...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...