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Committed to scientific and clinical research in breast milk
Prolact Product Safety

Research & Development

Laboratory Based Research

Macronutrient Analysis of a Nationwide Sample of Donor Breast Milk
As part of routine QA activity, incoming donor milk was tested for macronutrient content. Upon arrival, each donor’s milk was pooled into 10 liter aliquots, unique to that donor, and a sample of each aliquot was taken for testing. A total of 415 sequential samples from 273 donors were tested. A large variation in caloric and fat content was noted and a substantial proportion of donations tested had a caloric density of less than or equal to 17 calories/oz. The mean caloric density and the mean protein content were also found to be lower than generally assumed.

Wojcik KY, Rechtman DJ, Lee ML, et al. "Macronutrient Analysis of a Nationwide Sample of Donor Breast Milk" J Am Diet Assoc. 2009; 109: 137-140.
 
Longitudinal Study of the Immunological Properties of Milk
A study examining the immunological properties of milk longitudinally as a function of the time post-partum that the milk was expressed. (Churchill Hospital/Oxford University)

Rechtman DJ, Ferry B, Lee ML, and Chapel H. IgA content of human breast milk over time Presented at 12th International Symposium on Infections in the Immunocompromised Host Halifax Nova Scotia Canada June 2002.
 
IgA Over Time
The major milk components study is being performed at Churchill/Radcliffe Hospital associated with Oxford University, United Kingdom. This study is evaluating the total sIgA and specific IgA antibodies pre/post-pasteurization. Data to date suggests that sIgA levels in total vary among donors over time, but certain specific antibodies tend to stay high. Continued work will evaluate various specific sIgA antibodies to pathogens associated with necrotizing enterocolitis from longitudinally collected donor milk. This research will lead to a better understanding of the change in milk composition over time.

Submitted
 
Human Milk Stability
This formal experiment completed over a 12 month real-time period examined vitamins, lipid oxidation, and protein content of pasteurized whole milk stored at -20°C. Results showed stability for at least 24 months of storage. Data on file, Prolacta Bioscience (2010)

An accelerated study of the stability of Prolact+ H2MF® and milk products with a higher fat content indicated that these preparations could be stored for up to 24 months at -20°C without any untoward effect, particularly with regard to lipid oxidation. Data on file, Prolacta Bioscience (2010)

An evaluation of cold-chain stability was also conducted. Raw milk was subjected to several storage conditions, including thawing and refreezing. The finding showed that under laboratory conditions milk can be stored at 8°C for 24 hours or 23°C for 4 hours and can be refrozen up to three times with no significant bacterial growth.

Rechtman DJ, Lee ML and Berg H. Effect of environmental conditions on unpasteurized donor human milk. Breastfeeding Medicine 1:2006;24-26.
 
Biological Activity Study
A comparison of Prolact+ with cow’s milk-based fortifier in terms of their effect on the antimicrobial properties of breast milk. The study showed that the inherent anti—microbial effect of breast milk was almost totally eliminated by the addition of a commonly used cow’s milk-based fortifier to the breast milk. No measurable decrease in activity was seen when Prolact+ was added to the breast milk.

Chan GM, Lee ML, and Rechtman DJ. “Effects of a human-milk derived human milk fortifier on the antibacterial actions of human milk” Breastfeeding Medicine. 2007, 2(4): 205-208.

In Vitro Comparison of Human and Bovine Based HMFs
A comparison of Prolact+ H2MF® with cow’s milk-based fortifier in terms of their effect on the antimicrobial properties of breast milk. The study showed that the inherent anti-microbial effect of breast milk was almost totally eliminated by the addition of a commonly used cow’s milk-based fortifier to the breast milk. No measurable decrease in activity was seen when Prolact+ H2MF® was added to the breast milk.

Chan GM, Lee ML, and Rechtman DJ. "Effects of a human-milk derived human milk fortifier on the antibacterial actions of human milk" Breastfeeding Medicine. 2007, 2(4): 205-208.
 
In Vitro Study of Nutrient Delivery by Various Feeding Methods
Drs. Stefanie Rogers and Steven Abrams at Baylor University looked at the issue of loss of nutrients through feeding bags and tubing used in the enteral feeding of VLBW infants. They tested a variety of feeding methods and pumps. They found that when using continuous feeding there is loss of nutrients, particularly fat and calcium in the bag and tubing. This loss is worse with one specific type of peristaltic pump. The loss is also worse when milk is fortified with cow-milk based fortifier than when Prolact+ H2MF® is used as the fortifier. There was no significant nutrient loss with bolus feeds regardless of fortifier used, and intermediate loss with longer gavage feeds with the same advantage to fortification with Prolact+ H2MF® as seen with the pump. This research was presented in a podium presentation at the American Academy of Pediatrics Annual Meeting, October, 2008.

Stefanie P. Rogers, Penni D. Hicks, Maria Hamzo, Lauren E. Veit and Steven A. Abrams. "Continuous Feedings of Fortified Human Milk Lead to Nutrient Losses of Fat, Calcium and Phosphorous Nutrients" 2010, 2(3), 230-240; doi:10.3390/nu2030240
 
University of California at Davis
In collaboration with Dr. Bruce German at University of California at Davis the content of oligosaccharides pooled raw breast milk and in Neo20 was investigated. Breast milk has a spectrum of about 200 unique oligosaccharides, of which an individual mother will usually have about 50-60. Neo20 was found to contain all 200 oligosaccharides in the amounts that are typically found in breast milk. There was no loss of oligosaccharides as compared to the raw pooled milk. Additional work to quantify amounts of specific oligosaccharides is ongoing.
 
Potential Novel Source for Human Oligosaccharides
Barile D, Lebrilla DBC, German B, Rechtman DJ, and Lee ML. "Oligosaccharide prebiotics present in a breast milk based human milk fortifier" Presented at American Academy of Pediatrics National Conference and Exhibit, Washington DC 2009.
 
Oligosaccharide Prebiotics Present in Breast Milk Based Human Milk Fortifier
Barile D, German B, Lee ML, and Rechtman DJ. "Potential Novel Source for Human Oligosaccharides" Presented at American Academy of Pediatrics National Conference and Exhibit, Washington DC 2009.
 

Clinical Research Program


A Historically Controlled Cohort Study of a Novel Breast Milk-Based Human Milk Fortifier in Pre-term Infants: Effects on Growth, Respiratory Status and ROP

The goal of this study was to evaluate the effects of substituting Prolact+ H2MF® for powdered cow-milk based fortifiers on parameters such as feeding tolerance, growth and NEC rate. Acceptable rates of growth were achieved, feeds were well tolerated, and there was only one case of NEC, which did not require surgery, amoung the 66 infants in the cohort. The data were presented in a podium presentation at the American Academy of Pediatrics Annual Meeting, October, 2008.

Sullivan S, for The Prolacta Cohort Study Group. Use of a breast milk-based human milk fortifier in VLBW infants compared with standard bovine milk-based formula; a cohort study presented at 12th Annual International Meeting Academy of Breastfeeding Medicine, Fort Worth, Texas October, 2007.
 
A Randomized Study of Human Milk-Based vs. Bovine-based Nutrition for Very Low Birth Weight Preterm Infants
A randomized prospective clinical study comparing human milk-based fortification of mother's milk with the standard bovine-based fortifier or; for those infants whose mothers could not provide any breast milk a study of entirely bovine versus entirely human-based nutrition. The goal was to evaluate feeding tolerance as measured by days on total parenteral nutrition in these babies. Secondary outcomes included growth, incidence of sepsis, incidence of NEC and pharmacoeconomic parameters. Data presented at Pediatric Academic Societies annual meeting May 2, 2009, Baltimore, MD. Manuscript under revision.

Arm 1 - Study Completed - Multicenter

Arm 2 - Study Completed - Multicenter

For further study information: click here

A Controlled Clinical Trial of the Effect of Bovine Fortifiers vs. Prolact+ H2MF® on Fractional Calcium Uptake from the Gut and on Bone.

Study Completed and Published

Hicks PD, Rogers SP, Hawthorne KM, Chen Z, Abrams SA. "Calcium absorption in very low birth weight infants with and without bronchopulmonary dysplasia" J Pediatr. 2011 Jun;158(6):885-890.e1. Epub 2011 Feb 6.
 
Evaluation of Pre and Probiotics for the Nutritional Support of VLBW infants

Whether the prebiotic content oligosaccharides of Prolacta human milk products compared to probiotics will have any impact on the type of bacteria colonizing the intestinal tract of VLBW infants.

Study Completed
 
Gastroschisis Study

A study is being planned with Texas Children's Hospital to determine if the nutritional needs of infants whose volume of intake is highly restricted due to congenital abnormality can be met using Prolact+ H2MF®.

Rebecca E. Rawalt, MD, Keli M. Hawthrone, RD, Steven A. Abrams, MD Section of Neonatology, Baylor College of Medicine, Houston TX USDA/ARS Children's Nutrition Research Center, Houston TX.

"Human Milk May Improve Feeding Tolerance in Infants With Abdominal Wall Defects" Abstract presented at Pediatric Academic Societies 2011.

Study Completed
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