The full potential of human milk has yet to be realized. Speaking of Human Milk provides healthcare professionals with information on the latest science and clinical research. Each episode features an interview with a thought leader passionate about uncovering the unknown potential of human milk or better understanding the science of neonatal nutrition.
In addition to hosting Speaking of Human Milk, Keli Hawthorne is the director for clinical research for the Department of Pediatrics at the University of Texas Austin, Dell Medical School. In her current role, she trains faculty and staff on effectively executing high-quality protocols for research. She has authored more than 40 peer-reviewed publications on neonatal nutrition.
Keli Hawthorne: Hi y’all, welcome to Speaking of Human Milk, where we give you bitesize episodes on the latest science and innovation surrounding human milk. This podcast is brought to you by Prolacta Bioscience, a company dedicated to Advancing the Science of Human Milk. I’m your host Registered Dietitian Keli Hawthorne. For our very first episode I am excited to be joined by Dr. Martin Lee. Dr. Lee is Adjunct Professor at the Fielding School of Public Health at UCLA and Professor of Internal Medicine at Charles R. Drew University of Science and Medicine. He is also the VP of Clinical Research and Development at Prolacta Bioscience where he leads all research and development activities. He’s authored and co-authored more than 200 scientific papers and is considered a leading expert in the field of human milk. Dr. Lee, thank you for joining us.
Dr. Martin Lee: Thank you for having me and I’m honored to be your first guest!
Keli Hawthorne: I’d like to jump right in. For this episode we wanted to delve into the earliest research that influenced our understanding of the importance of a human milk diet for premature infants. Can you tell us what were some of these earliest studies and what they revealed?
Dr. Martin Lee: Relatively large-scale randomized studies conducted in the 1980’s on low birth weight, pre-term babies led by Indira Narayanan in India and Alan Lucas in the UK laid the groundwork for demonstrating that the exclusive use of breast and donor milk provided a diet that could prevent the major morbidities, particularly infections, and even mortality associated with prematurity. However, given the dietary needs of these infants for significant amounts of protein, calories and other macronutrients suggested that additional supplementation of the diet was needed. The first published attempt at human milk fortification was performed by Modanlou and colleagues in 1986 and demonstrated better in-house weight gain compared to a non-fortified diet. However, this and subsequent fortifiers were made from cow’s milk.
Keli Hawthorne: It’s incredible how far we’ve come. Can you describe how this work culminated into the idea of creating a fortifier made from donor milk?
Dr. Martin Lee: Based on these pioneer findings regarding the importance of a human milk diet and the significance of fortification for the development of the premature infant, led to the idea that a fortifier made from human milk would allow for a completely human milk-diet for these babies that could potentially provide the protection afforded by human milk with the additional nutrients needed for growth and development without exposure to cow’s milk.
Keli Hawthorne: How did you get involved with making a human milk fortifier from donor milk?
Dr. Martin Lee: At the very beginnings of Prolacta nearly 20 years ago, we knew that it was theoretically and practically possible to produce a concentrated human milk formulation that could serve as a fortifier for human milk. The concept had been proposed earlier by researchers such as Lucas and Polberger. The issue for us was to work through the specific procedures that would ensure a nutritional product that could consistently be used in the premature infants who might benefit from it. Furthermore, it was important to produce such a product in different caloric strengths and provide the necessary protein content depending on the nutritional needs of these babies. Through the determination and efforts of the small group of manufacturing, quality and medical personnel over a several year period, this goal was finally achieved.
Keli Hawthorne: I know the first study on the human milk-based fortifier was published in 2010. I was thrilled to be part of it and I can’t believe it’s already been almost 10 years! What did we learn from that first study?
Dr. Martin Lee: As I just mentioned, much effort went into the production of the first batches of Prolacta’s human milk fortifier, Prolact+. However, it had been clear to us from the beginning that sound scientific studies in the form of well-designed clinical trials were necessary to convince the neonatology community, that a completely human milk-fed diet was medically better than the standard nutritional approach being employed at the time the studies began in 2007. We embarked on two separate studies performed in parallel on infants born under 1250 grams: those that were going to receive milk from their mother and those that were not. Both studies were performed as randomized trials to ensure the best possible design to evaluate the complete human milk compared to one in which cow’s milk-based nutrition was used as a supplement to mother’s own milk. What we found was quite clinically significant! In the study for which all babies initially received their own mother’s milk (and for which there were a total of 207 participants), we found a 77% reduction in the overall incidence of necrotizing enterocolitis or NEC when babies were fed nothing but human milk-based nutrition. Moreover, the rate of NEC requiring surgery was reduced 8-fold. The second study, where the babies did not receive milk from their mother, similar findings were seen and also a clinically important reduction in the number of days the infant required parenteral nutrition. Finally, when both of these studies were combined into a type of “meta-analysis”, we discovered a 4-fold reduction in mortality and a clear relationship between the amount of exposure to cow’s milk and an increased risk of late onset sepsis and other key facets of prematurity.
Keli Hawthorne: What about this research is most rewarding for you?
Dr. Martin Lee: One of the hallmarks of what we have always been about at Prolacta is trying to assist the medical personnel in neonatal intensive care units around the world to save their patients from the devastation of prematurity. Indeed, at Prolacta we work to save babies. Every year for the past few years, each employee receives an ornament during the holiday season with a number on it. Last year it was 665. This is an estimate of the number of babies’ lives saved that year from our work in providing a completely human milk diet. For me, this is the culmination of the work we all embarked on almost 20 years ago and what has the most meaning for me.
Keli Hawthorne: What’s on the horizon for premature infant nutrition?
Dr. Martin Lee: We recognized a few years ago that there are different populations of infants, some preterm, some term, who are born with various congenital issues that necessitate almost immediate surgery and for which a specialized fortifier could help in their nutrition and recovery post-surgery. We are currently working on studies in infants who are born with cardiac and gastrointestinal defects to demonstrate this proposition. We do this not because these are huge populations, but because we know that a specialized human milk fortifier could support their growth and recovery. The idea of potentially helping any infant with the precious gift of human milk is what Prolacta has always been about. Keli Hawthorne: Thanks for listening to this week’s episode of Speaking of Human Milk, powered by Prolacta Bioscience, a company dedicated to Advancing the Science of Human Milk. For more information on the company visit www.prolacta.com. Also, links to studies discussed in this episode are in the description.