Results from Study of Mead Johnson's Enfamil Human Milk Fortifier Acidified Liquid Published in Pediatrics

Mead Johnson is the first company to make available an ultra-concentrated liquid fortifier with nearly 20 percent more protein than current powdered fortifiers when added to breast milk.

18 Sep 2012 --- Mead Johnson Nutrition announced results of a new study published in Pediatrics that shows Enfamil Human Milk Fortifier Acidified Liquid supports significantly higher growth in premature infants than powdered fortifiers and is well-tolerated. Enfamil Human Milk Fortifier Acidified Liquid is the first and only ultra-concentrated liquid human milk fortifier marketed in the United States that meets safety guidelines from the Academy of Nutrition and Dietetics (AND) and Centers for Disease Control and Prevention (CDC), as well as new preterm nutrition guidelines from the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

The study is being released online, and will appear in the October print edition of Pediatrics. It was also selected for presentation in December 2012 at Hot Topics, the nation's premiere neonatal conference, with anticipated attendance of more than 1,000 neonatologists and perinatologists.

Breast milk provides important nutrients and immune factors to help meet the nutritional needs of infants and minimize the risk of illness and other complications. However, breast milk alone may not fully meet the nutritional needs of premature infants. Even currently available powdered human milk fortifiers may not support the increased protein needs of low birth weight infants. The CDC and AND have recommended that for premature or immune-compromised infants, sterile liquid products be used instead of powdered products in the NICU, where nutritionally appropriate. Mead Johnson is the first company to make available an ultra-concentrated liquid fortifier with nearly 20 percent more protein than current powdered fortifiers when added to breast milk. This ultra-concentrated fortifier minimizes the dilution of breast milk and provides the higher protein levels needed by preterm infants.

"Although liquid fortifiers are already recognized as the new standard of care, this is the first study to demonstrate the nutritional and safety benefits of ultra-concentrated liquid human milk fortifiers over powdered versions," said study co-author, Carol Lynn Berseth, M.D., director of medical affairs, Mead Johnson Nutrition. "With the development of ultra-concentrated Enfamil Liquid Milk Fortifier, Mead Johnson continues to demonstrate its leadership in pediatric nutrition innovation."

In the third-party blinded, stratified, controlled trial, 146 preterm infants with a gestational age of 23.7 – 30.4 weeks and birth weights between 530 to 1,250 grams received human milk and were randomized to receive Enfamil powder human milk fortifier (control group; 1.1 g protein/4 sachets) or Enfamil Human Milk Fortifier Acidified Liquid (1.8 g protein/4 vials) for 28 days. Weight and length growth were measured on day 28 and metabolic outcomes and other important outcomes such as necrotizing entercolitis (NEC), a gastrointestinal disease that mostly affects premature infants, and sepsis, a serious infection usually caused by bacteria that make toxins that cause the immune system to attack the body's own organs and tissues, were measured on days 14 and 28.4 To ensure the highest quality results, Mead Johnson collaborated with a Data Monitoring Board of three industry-leading neonatal academic specialists with expertise in clinical care, neonatal nutrition and statistical design to design and monitor outcomes throughout the study.

Infants who received the Enfamil Human Milk Fortifier Acidified Liquid showed significantly higher linear growth (41.8+/-0.24 vs. 40.0+/-0.23 cm, p=0.010) and weight growth (1770+/-35 vs. 1670+/-33, p=0.038) than the control group. Common markers of protein status, such as prealbumin, albumin and blood urea nitrogen (BUN), were also higher in the liquid human milk fortifier group versus the control group. No infants were treated for acidosis. Further, the study showed no statistically significant difference in the incidence of NEC or sepsis versus the control group. The study demonstrates Enfamil Human Milk Fortifier Acidified Liquid is not only clinically proven to provide better growth than Enfamil powdered fortifier, but is also safe and well-tolerated among preterm infants.

ESPGHAN recommends 3.6 to 4.1 g protein per 100 calories for infants weighing less than 1,000 g. When mixed with breast milk, Enfamil Human Milk Fortifier Acidified Liquid provides 4 g protein per 100 calories, which was shown to promote significantly higher weight, length, head circumference and linear growth than Enfamil powdered fortifier. Linear growth is recommended as a better measure of postnatal growth in premature infants than fat mass deposition.6 Enfamil Liquid Fortifier also has 24 mg of DHA and 38 mg of ARA per 100 calories when combined with breast milk to help support optimal visual and cognitive development in premature infants.7 Enfamil Human Milk Fortifier Acidified Liquid is the first and only ultra-concentrated human milk fortifier to have DHA and ARA.

Enfamil Human Milk Fortifier Acidified Liquid is provided in single-dose packaging, commercially sterile and free of microorganisms. The CDC, AND and U.S. FDA have recommended that sterile liquid products be used instead of powdered products for premature or immune-compromised infants. The AND's amended guidelines suggest using ready-to-feed or concentrated formulas rather than powdered formulas in NICUs. 8

"Mead Johnson designed this ultra-concentrated form of Enfamil Human Milk Fortifier Acidified Liquid to meet the nutritional needs of rapidly growing premature infants, while minimizing the dilution of the mother's breast milk which provides important health benefits," said Dr. Colin Rudolph, vice president, global medical affairs and chief medical officer, Mead Johnson Nutrition. "From the science of making our product to the support of breastfeeding moms, we are committed to helping give babies the best start in life."