Frequently Asked Questions

Company

1. What does Prolacta do?
   Prolacta is a research driven company dedicated to advancing the science of human milk. We produce specialty nutritional formulations made exclusively from human milk for critically ill premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. All our products are clinically proven to meet the needs of these infants. Prolacta is the first and only company to produce an HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. made from 100% human milk, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk.™. It is added to mothers’ own milk or to donor milk. 

2. Are there other companies or organizations that offer HMFs made from human milk?
   Prolacta is the first and only company to provide a fortifier made from 100% human milk; Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk.. Our products are specialty formulations of human milk that meet the nutritional needs of premature and critically ill infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., as prescribed by neonatologists. 

3. Is Prolacta a for-profit company?
   Yes. We have invested over 30 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model. 

4. Is Prolacta a milk bank?
   No. We assist in the organization of independently run and operated affiliate milk banks. 

5. Are you competing against non-profit milk banks?
   No. Prolacta’s lead product, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., is specially designed to be used with mother’s own milk, which is the best possible nutrition for critically ill premature infants. We are the only organization to provide HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. made from 100% human milk. It is our objective to provide the best possible nutritional formulations made from 100% human milk for the premature baby while receiving care in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. 

Products

1. What are your products?
   Prolacta’s commitment to advancing the science of human milk has led us to develop and offer the only HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients. derived from 100% human milk, as opposed to other HMFs which are derived from cow’s milk. Our line of fortifiers, Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., provide VLBWVLBW
   Very low birth weight; a baby weighing 1,500g or less. premature infants with the nutrition necessary to support appropriate growth and development. Prolacta’s human milk-based products have been formulated to deliver exact caloric and protein levels every time. These products are critical to premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. who require higher levels of protein and calories than can be provided by mothers' milk alone. 

2. Where are your products being used?
   Prolacta's completely human milk formulations are used in NICUsNICU
   Neonatal/Newborn Intensive Care Unit. across the nation, for the most fragile babies. 

3. How do you get human milk for your products?
   Prolacta receives breast milk donations from dedicated, healthy, nursing women who have undergone extensive medical and social screening similar to the blood donor screening process. 

4. How do I know Prolacta’s products will work?
   A growing body of data from clinical trials has shown positive results in infants that have used Prolacta's human milk fortifier products. Earlier studies have also demonstrated that for infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., human milk decreases the incidence of diseases such as necrotizing enterocolitis (NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants.), bronchopulmonary dysplasia (BPD), and sepsis (infection). 

5. Are there any side effects?
   There are currently no known side effects based on the six clinical trials and significant commercial use of the products. Prolacta continues to monitor the products in the same way that other therapeutic products are monitored. 

6. Why is it vital that critically ill premature infants get additional calories, fat, protein and minerals?
   Critically ill premature infants have special dietary needs requiring higher levels of protein and calories than a full-term baby would need. These needs are usually met by blood delivered through the mother's placenta during the last trimester of pregnancy. Unfortunately, premature infants miss out on this important period of development, so the increased nutrition is provided by supplementing mother’s own milk with HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients..

   Clinical trials were conducted which showed major improvements with the use of fortifier in growth and developmental outcomes for premature infants. Fortification is now considered standard of care for these infants and not to fortify their milk would be considered unethical under almost all circumstances. 

7. What is the current standard of care for fortification of human milk in the NICU?
   The current standard is to use powdered, cow milk-based products to fortify human milk. Premature infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit. may become intolerant to these preparations. 

8. What is the average size baby that uses Prolacta products?
   The average baby that was evaluated in our clinical studies was approximately 950 grams (2.14 pounds) at birth. Prolacta recommends the use of its products in babies weighing less than 1250 grams (2.75 pounds) at birth. 

9. Should a mother try to produce breast milk while her baby is receiving Prolacta’s products in the NICU?
   Absolutely. A mother's milk is the gold standard of nutrition. Prolacta's fortifier was specially designed to be used with mothers’ own milk. This combination will provide infants with the best possible nutrition. 

10. Does Prolacta have proof that human milk is better than formula?
    There are numerous studies that demonstrate the superiority of human milk over cow milk as the best nutrition for babies. These and other data have led the American Academy of Pediatrics (Click to visit website) to state that breastfeeding is important for optimal infant and child health. Additionally, a recently completed randomized, controlled clinical trial presented at PAS (Click here to view abstract) has demonstrated that a completely human milk based diet, including Prolact+ H²MFProlact+ H²MF
    Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk., reduced the incidence and severity of NECNEC
    Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. in premature infants weighing ≤1250g at birth. 

Safety & Processing

1. How do I know the products are safe?
   Our dedication to advancing the science of human milk has led us to build a one-of-a-kind, state of the art manufacturing facility. Our products have been safely used in NICUsNICU
   Neonatal/Newborn Intensive Care Unit. in the U.S. and Europe. We use the most sophisticated and innovative processes, pasteurization, and filling methods to ensure the highest possible level of product safety, and quality. This includes final testing for microbiological contamination and with Polymerase chain reaction is a method to analyze a short sequence of DNADNA
   Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. (or RNARNA
   Ribonucleic acid, in some viruses, performs the role of DNA.) even in samples containing only minute quantities of DNADNA
   Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. or RNARNA
   Ribonucleic acid, in some viruses, performs the role of DNA.. for virus that can detect as little as one copy of the virus. 

2. Is Prolacta regulated by any federal or state agencies?
   Yes. Prolacta products are regulated by the FDA. Prolacta's facility is licensed as a tissue bank by the states of California and New York, which are the only two states that require such a license. 

3. How do you know your process kills bacteria and inactivates viruses?
   Testing performed at independent laboratories has shown that our process inactivates HIVHIV
   Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). , HBVHBV
   The hepatitis B virus is a cause of hepatitis, a liver disease. It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver failure or liver cancer., CMVCMV
   Cytomegalovirus is a group of human herpes viruses that can cause birth defects and can affect humans with impaired immunological systems. and HCVHCV
   The hepatitis C virus is a cause of hepatitis, a liver disease. HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer. and is effective against intra and extra cellular virus. It also kills bacteria such as Staphylococcus and E. coli. 

4. How are Prolacta products able to meet the unique nutritional needs of the VLBW premature infants?
   By concentrating human milk proteins and providing them in different volumes, Prolacta formulations give neonatologists the widest range of options to meet the latest nutritional recommendations for critically ill premature infants from leading neonatal experts. 

Donors

1. How are donors screened prior to donating milk?
   Breast milk donations follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:

   1. Potential donors are screened through a medical history survey. After the screening, the donor is entered into Prolacta’s secure database and assigned a donor number.
   2. Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby’s pediatrician before she can continue in the donation process.
   3. The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.
   4. A blood test and a DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. cheek swab are conducted. The blood test screens for several infectious agents including HIVHIV
      Human immunodeficiency virus is the virus that causes acquired immune deficiency syndrome (AIDS). 1&2, HTLVHTLV
      Human T- lymphotropic virus is a retrovirus that causes some forms of lymphoma, and is in the same class of virus as the AIDS virus, HIV-1. I&II, HBVHBV
      The hepatitis B virus is a cause of hepatitis, a liver disease. It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver failure or liver cancer., HCVHCV
      The hepatitis C virus is a cause of hepatitis, a liver disease. HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer., and syphilis. The DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. cheek swab is used to create a donor DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. ID. This DNADNA
      Deoxyribonucleic acid is the fundamental building block of an individual's entire genetic makeup. ID will be used later to ensure the milk received is from the donor that was blood tested.
   5. If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and have another blood test.

    

2. Does Prolacta pay donors?
   Our aim is to collect and process only a mother’s surplus milk – milk that may otherwise be poured down the drain. To that end, we would not want to provide any financial incentive for a mother to donate milk which would, and should, be fed to her own infant.

   In addition to the donor milk being used to make nutritional products for infants in the NICUNICU
   Neonatal/Newborn Intensive Care Unit., Prolacta partners with charitable organizations and provides direct financial contributions for the milk that is collected. Our relationship with the International Breast Milk Project was the first such partnership. 

Product Costs

1. How much does a course of Prolact+ H²MF cost for a premature infant in the NICU?
   Price is entirely dependent on the size and gestational age of the baby. Prolacta’s products are intended to support the initiation and advancement of enteral feedings and the fortification of mother’s own milk. With the average NICUNICU
   Neonatal/Newborn Intensive Care Unit. hospital bill for a 12 week premature infant exceeding $500,000, Prolacta’s products represent less than two percent of the bill. 

2. Do Prolacta products cost more than donor milk from a milk bank?
   Prolacta human milk formulations are not the same as donor milk from a milk bank. We use the most sophisticated and innovative processes, pasteurization, and filling methods to ensure the highest possible level of product safety, and quality. This includes final testing for microbiological contamination and using PCRPCR
   Polymerase chain reaction is a method to analyze a short sequence of DNA (or RNA) even in samples containing only minute quantities of DNA or RNA. testing for viruses that can detect as little as one copy of the virus. Our products are concentrated to create standardized formulations for use in the NICUNICU
   Neonatal/Newborn Intensive Care Unit.. Additionally, we are the only company to offer a complete human milk-based HMFHMF
   Human milk fortifier is a milk-based nutritional supplement and is mixed with mother's milk or donor milk to increase the levels of protein, energy, calcium, phosphorus, and other nutrients., Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk.; therefore, there is no direct comparison to donor milk from other milk banks. 

3. Who pays for Prolacta products?
   The cost of Prolacta products is, in most cases, under two percent of the total cost of care for a VLBW infant. Prolacta’s products are treated in the same manner as are most products used to provide patient care in hospital. Prolacta never charges a parent for product. In many cases medical insurance covers the cost of the products. In other cases hospitals are willing to absorb the cost. In fact, hospitals and the health care system save money using Prolact+ H²MFProlact+ H²MF
   Human milk-based, human milk fortifier. Manufactured by Prolacta Bioscience, it is the only human milk fortifier made from 100% human milk. because of the cost savings realized due to the reduced incidence and severity of NECNEC
   Necrotizing enterocolitis is an acute inflammatory disease affecting the intestines of premature infants. seen in our clinical trial.