Common questions about Prolacta (FAQ)
Q: Why is Prolacta used primarily in the NICU or for premature babies?
According to official product information, Prolacta is a specialized nutritional preparation designed for critically ill, premature infants. It is most often used in the Neonatal Intensive Care Unit (NICU) as part of an Exclusive Human Milk Diet (EHMD) for infants who require highly targeted nutrition.
Q: What is the source material for Prolacta?
Official information states that Prolacta is made from 100% pasteurized donor human milk collected from carefully screened donors under regulated conditions to ensure safety and consistency.
Q: Does Prolacta contain any common allergens, like soy or nuts?
According to the official product labeling, Prolacta fortifiers and formulas are 100% human milk-based. They are manufactured to be free from cow milk and do not contain common added synthetic ingredients such as corn syrup.
Q: How is Prolacta different from regular human milk?
Prolacta is different because it is processed to be highly standardized and concentrated. This process is designed to deliver consistent, higher levels of protein, fat, and calories than unfortified human milk. Essential minerals may also be added to meet the intense nutritional requirements of premature infants.
Q: Is Prolacta the same as donor milk?
While Prolacta originates from donor human milk, it undergoes extensive processing and testing. It is pasteurized and standardized in pharmaceutical-grade facilities, and then concentrated into a fortifier or formula, unlike raw or simply banked donor milk.
Q: What is the difference between Prolacta and other nutritional fortifiers?
The official product information characterizes Prolacta as being 100% human milk-based. This distinction is based on the fact that it is free from cow milk and added synthetic ingredients found in some other common fortifiers.
Q: Does Prolacta help with brain development in infants?
Studies associated with the use of Prolacta products indicate support for adequate physical growth. This support is associated with improvements in anthropometric measurements, such as head circumference, which is sometimes used as an indicator of brain growth.
Q: Is there evidence that Prolacta reduces the risk of NEC (Necrotizing Enterocolitis)?
Evidence from clinical studies on an Exclusive Human Milk Diet (EHMD) using Prolacta products suggests a significantly decreased incidence of Necrotizing Enterocolitis (NEC). This finding is often observed when compared to diets that rely on cow milk-based products.
Q: Where does the research for Prolacta typically come from?
The research supporting the product is often published in established peer-reviewed medical journals, such as the Journal of Perinatology or Breastfeeding Medicine. This evidence is generated through the manufacturer's clinical program and various external trials.
Q: Why do official documents refer to Prolacta as a 'human milk-based fortifier'?
Official documents use this term to describe the product's composition and function. The human milk-based part refers to its 100% donor milk source, while fortifier refers to its role in increasing the nutrient content of human milk for vulnerable infants.
Q: Is Prolacta licensed or approved in countries outside of the US?
Official regulatory compliance is noted in various regions globally, as evidenced by registration with bodies like Food Standards Australia New Zealand (FSANZ). This demonstrates compliance with regulatory requirements for international distribution.
Q: Does Prolacta contain any synthetic or artificial ingredients?
According to the official labeling, Prolacta's products intended for extremely premature infants are manufactured to be free from added synthetic ingredients, such as corn syrup. They are composed entirely of human milk components.
Q: How does the manufacturing process ensure the safety of Prolacta?
The processing steps are designed to enhance the safety profile of Prolacta through manufacturing in pharmaceutical-grade facilities. The milk undergoes pasteurization and over 20 validated tests to screen for pathogens, drugs, and contaminants, with processes modeled after the U.S. blood industries.
Q: Are there different versions or concentrations of Prolacta?
The manufacturer does produce different versions and concentrations of the product. This includes fortifiers, such as Prolact+ H2MF, and ready-to-feed formulas with varying nutrient profiles (e.g., Prolact RTF).
Q: What should parents know about the protein content in Prolacta?
The official product nutritional information details that Prolacta fortifiers contain standardized amounts of protein, fat, and carbohydrate derived from human milk. These specific nutrient profiles are designed to meet the high metabolic demands of premature infants.
Q: Does the use of Prolacta have any impact on a baby's weight gain goals?
Clinical studies using Prolacta fortifiers as part of an Exclusive Human Milk Diet (EHMD) have indicated support for adequate growth. This support may include improvements in anthropometric goals such as weight, length, and head circumference.
Q: Is it normal for Prolacta to change color or consistency?
Handling and storage guidelines emphasize maintaining the product's integrity through specific protocols, such as continuous freezing at le -20 C. While minor variation is inherent, significant changes in appearance may be a sign of improper handling or storage.
Q: Can Prolacta be given alongside formula, or is it exclusively for use with human milk?
Official documentation indicates that Prolacta is designed and clinically studied as part of an Exclusive Human Milk Diet (EHMD). In this diet, all necessary nutrients are derived only from human milk.
Q: What is the role of the fortification component in Prolacta?
The official role of the fortification component is to provide concentrated calories and protein to help premature infants meet their specific nutritional targets required for healthy growth and development.
Q: Does Prolacta have a specific classification regarding infectious disease screening?
The company employs comprehensive infectious disease screening processes for both the donor and the milk itself. These safety standards are often modeled on the processes used in the U.S. blood and plasma industries, including Nucleic Acid Amplification Testing (NAAT).
Q: How does Prolacta fit into the overall nutritional plan for a critically ill infant?
Prolacta is intended to serve as the nutritional basis for a critically ill infant’s Exclusive Human Milk Diet (EHMD). It is specifically used for infants weighing le 1250 grams, or those with complex medical needs, to promote the goal of receiving human milk-based nutrition.
Q: Is there a maximum or minimum weight a baby must be to start Prolacta?
Official evidence indicates that the products are primarily studied and intended for the most vulnerable infants. This includes Very Low Birth Weight (VLBW) infants, typically weighing le 1250 grams, and those recovering from certain complex medical conditions.
Q: What evidence exists regarding the impact of Prolacta on feeding tolerance?
Clinical data suggests that an EHMD using Prolacta fortifiers is associated with decreased incidence of feeding intolerance and reduced complications in preterm infants.
Q: Is the nutritional content of Prolacta standardized across batches?
Yes, Prolacta products are manufactured under rigorous quality standards and are standardized. This process is designed to support the predictable delivery of a consistent amount of key nutrients, which helps healthcare providers manage the infant's nutrition accurately.
Q: Why is high-level protein important in products like Prolacta for premature infants?
High protein levels are included in fortifiers to help meet the nutritional targets recommended by the National Academy of Medicine and to address the risk of inadequate nutrition facing low birth weight infants.
Q: Is there any difference in how Prolacta is handled compared to other donor products?
Prolacta is typically managed according to strict protocols derived from its pharmaceutical-grade manufacturing. This often involves specific storage and thaw times that can differ from the more general handling guidelines applied to other banked donor milk products.
Q: Does Prolacta carry a risk of contamination from the original donor milk?
Official safety standards address the risk of contamination by employing extensive donor screening, rigorous testing (over 20 tests on the milk), and pasteurization. These measures are designed to significantly reduce the risk of pathogen transmission.
Q: What is meant by the 'standardization' of human milk components in Prolacta?
Standardization refers to the process of testing and processing the donor milk to support the goal of delivering a consistent, predictable amount of key nutrients. This is necessary because the nutrient content of mother's own milk can naturally vary widely.
