Enrollment Completed in Clinical Trial Evaluating Effect of Exclusive Human Milk Diet Including a Specialty Fortifier in Term Infants Born With Single Ventricle Physiology

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Apr 07, 2021, 09:00 ET

DUARTE, Calif., April 7, 2021 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, announced today that enrollment is now complete in a clinical trial evaluating the effect of an exclusive human milk diet (EHMD),¹ including a specialty fortifier, for term infants who have undergone a corrective procedure for single ventricle physiology (SVP), a life-threatening congenital heart defect (CHD).

SVP refers to many types of CHDs that include specific anatomical conditions that result in the body having only one functioning heart ventricle. Because the body needs two healthy heart ventricles to pump blood around the body successfully, infants with SVP may have severe complications unless treated through a series of surgeries shortly after birth.²

"We're hopeful that an EHMD, including a specialty fortifier, will demonstrate improved short- and long-term health outcomes for this population of fragile term infants," said principal investigator Dr. Cynthia Blanco, MD, of the University of Texas Health Science Center in San Antonio. "This study allows us to examine the role of human milk nutrition for this specific infant population who require a great deal of nutrients to catch up on growth, heal from multiple surgeries, and avoid further health complications."

Blanco approached Prolacta about developing a fortifier for infants requiring cardiac surgery. SVP is rare, with only approximately 1,500 infants a year born in the U.S. with this condition.³ These infants face growth and feeding intolerance issues, which are further complicated by the infants being severely fluid restricted. To meet the specific nutritional needs of these fragile infants requiring surgery, a specialty fortifier was developed and evaluated for potential use in this specific patient population.

"We were moved by Dr. Blanco's commitment to her patients and wanted to help her feed these fragile single ventricle physiology infants undergoing a corrective procedure," said Scott Elster, CEO of Prolacta. "It is gratifying to have the opportunity to provide human milk nutrition to other infant populations in need — regardless of the relative size of that patient population."

The study, "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," successfully enrolled 107 infants undergoing a corrective procedure for SVP. These infants were randomly assigned to receive either Prolacta's human milk-based fortifier as part of an EHMD, or a cow milk-based fortifier as part of a human/cow milk diet (depending on hospital protocol). The trial was conducted at major medical centers in Texas, Ohio, Oklahoma, California, Illinois, New York, and Florida.

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.⁴ 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. 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
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310.721.9444

References:

1. An exclusive human milk diet (EHMD) is achieved when 100% of 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. Single Ventricle Defects. American Heart Association (AHA). Accessed January 13, 2021. https://www.heart.org/en/health-topics/congenital-heart-defects/about-congenital-heart-defects/single-ventricle-defects

3. Estimated number of infants born with hypoplastic left heart syndrome including single ventricle physiology based on findings from: Centers for Disease Control and Prevention. Facts about Hypoplastic Left Heart Syndrome. Accessed March 19, 2021. https://www.cdc.gov/ncbddd/heartdefects/hlhs.html; data on file.

4. Estimated number of premature infants fed Prolacta's products from January 2007 to August 2020; data on file.

SOURCE Prolacta Bioscience