Results from study of Mead Johnson's Enfamil® Human Milk Fortifier Acidified Liquid published in Pediatrics

Enfamil Human Milk Fortifier supported significantly higher growth than Enfamil Powdered Fortifier

2012-09-17

(Press-News.org) [GLENVIEW, Ill., Sept. 17, 2012] – Mead Johnson Nutrition (NYSE: MJN) announced today 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 today, 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.1 Even currently available powdered human milk fortifiers may not support the increased protein needs of low birth weight infants.2 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.3 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.4

ESPGHAN recommends 3.6 to 4.1 g protein per 100 calories for infants weighing less than 1,000 g5. 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."

### The study is sponsored by Mead Johnson Nutrition. Study authors include: Fernando Moya, MD: Coastal Carolina University Neonatology, Wilmington, North Carolina; Paula M. Sisk, PhD: Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, North Carolina; Kelly R. Walsh, PhD, RD: Department of Nutrition Science, Research and Development, Mead Johnson Nutrition, Evansville, Indiana; and Carol Lynn Berseth, MD: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, Indiana.

About Mead Johnson Mead Johnson, a global leader in pediatric nutrition, develops, manufactures, markets and distributes more than 70 products in over 50 markets worldwide. The company's mission is to nourish the world's children for the best start in life. The Mead Johnson name has been associated with science-based pediatric nutrition products for over 100 years. The company's "Enfa" family of brands, including Enfamil® infant formula, is the world's leading brand franchise in pediatric nutrition.

For more information on the company, go to www.meadjohnson.com.

Mead Johnson Nutrition Company Media Contact: Chris Perille, 847-832-2178
chris.perille@mjn.com References: 1. Schanler RJ. Evaluation of the evidence to support current recommendations to meet the needs of premature infants: the role of human mil. The American Journal of Clinical Nutrition. 2007; 85(2): 625S-628S 2. Arslanoglu S, Moro GE, Ziegler EE. Preterm infants fed fortified human milk receive less protein than they need. J Perinatol. 2009;29(7):489-492 3. Baker, RD. Infant formula safety. 2002; 110(4):833 – 835 4. Moya F, Sisk P, Walsh K, Berseth C. A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics. 2012;130(4) 5. Enteral nutrient supply for preterm infants. A comment of the ESPGHAN Committee on Nutrition. 6. Sauer PJ. Can extrauterine growth approximate intrauterine growth? Should it? The American Journal of Clinical Nutrition. 2007;85(2):608S-13S 7. Koletzko, B. Lien, E. Agostoni, C. et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J. Perinat. Med. 2008; 36: 5-14. http://www.ncbi.nlm.nih.gov/pubmed/18184094 8. Baker, RD. Infant formula safety. 2002; 110(4):833 – 835

ELSE PRESS RELEASES FROM THIS DATE:

Sorghum eyed as a southern bioenergy crop

2012-09-17

Sweet sorghum is primarily grown in the United States as a source of sugar for syrup and molasses. But the sturdy grass has other attributes that could make it uniquely suited to production as a bioenergy crop, U.S. Department of Agriculture (USDA) studies suggest. Sorghum is an ideal candidate because of its drought tolerance, adaptability to diverse growing conditions, low nitrogen fertilizer requirements, and high biomass (plant material) content, according to molecular biologist Scott Sattler and collaborator Jeff Pedersen with USDA's Agricultural Research Service ...

Effectiveness and impact of climate change mitigation measures unclear

2012-09-17

Uncertainties relating to the assessment of effectiveness of emission reduction measures are considerable. In order to manage these, there is an evident need to develop uniform assessment methods for ensuring that the assumed emission reductions are also achieved in practice. Significant mitigation of climate change is widely supported globally. Achieving the mitigation targets will require considerable reductions in global greenhouse gas emissions in the coming years. However, widely differing views, particularly of the large economies such as the EU, the United States, ...

Food industry's high-quality co-streams used effectively as raw material for new products

2012-09-17

Co-streams from the food industry are excellent sources of proteins and healthy oils for use in foods and cosmetics. However, at the moment these side streams are mainly used as fish and animal feed, for energy, or end up as waste. Coordinated by VTT, the APROPOS (Added value from high protein and high oil containing industrial co-streams) project seeks to enrich several co-stream components at once from food quality co-streams of rapeseed/canola/mustard and fish. In particular, this project aims to promote the competitiveness of the SME sector and developing regional ...

VTT and GE Healthcare developing novel biomarkers to predict Alzheimer's disease

2012-09-17

Alzheimer's disease (AD) is a growing challenge to the health care systems and economies of developed countries with millions of patients suffering from this disease and increasing numbers of new cases diagnosed annually with the increasing ageing of populations. Early detection of prodromal AD is vital both for assessing the efficacy of potential AD therapeutic agents as well as new disease modifying therapies are most likely to be effective when initiated during the early stages of disease. The elucidation of early metabolic pathways associated with progression to Alzheimer's ...

Your body doesn't lie: People ignore political ads of candidates they oppose

2012-09-17

COLUMBUS, Ohio - A recent study examined people's bodily responses while watching presidential campaign ads - and discovered another way that people avoid political information that challenges their beliefs. In the last days of the 2008 campaign, researchers had people watch a variety of actual ads for Republican presidential candidate John McCain and his Democratic rival Barack Obama while the viewers' heart rates, skin conductance and activation of facial muscles were monitored. The results showed that partisan participants reacted strongly to ads featuring their ...

Mobile phones and wireless networks: No evidence of health risk found

2012-09-17

There is no scientific evidence that low-level electromagnetic field exposure from mobile phones and other transmitting devices causes adverse health effects, according to a report presented by a Norwegian Expert Committee. In addition, the Committee provides advice to authorities about risk management and regulatory practice. The Committee has assessed the health hazards from low-level electromagnetic fields generated by radio transmitters. These electromagnetic fields are found around mobile phones, wireless phones and networks, mobile phone base stations, broadcasting ...

At the right place at the right time -- new insights into muscle stem cells

2012-09-17

Muscles have a pool of stem cells which provides a source for muscle growth and for regeneration of injured muscles. The stem cells must reside in special niches of the muscle for efficient growth and repair. The developmental biologists Dr. Dominique Bröhl and Prof. Carmen Birchmeier of the Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch have elucidated how these stem cells colonize these niches. At the same time, they show that the stem cells weaken when, due to a mutation, they locate outside of the muscle fibers instead of in their stem cell niches (Developmental ...

Added benefit of Cannabis sativa for spasticity due to multiple sclerosis is not proven

2012-09-17

An extract from the plant Cannabis sativa (trade name Sativex®) was approved in May 2011 for patients suffering from moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS). In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new drug, which is used as a mouth spray, offers an added benefit over the optimized standard therapy. However, no such added benefit can be inferred from the dossier, ...

Rapid intensification of global struggle for land

2012-09-17

The earth's limited surface is expected to stretch to everything: food for soon to be nine billion people, feed for our beef cattle and fowl, fuel for our cars, forests for our paper, cotton for our clothes. What is more, the earth's forests are preferably to be left untouched to stabilise the climate. Human ecologist and economist Kenneth Hermele will shortly be defending a thesis at Lund University, Sweden, in which he demonstrates that the struggle for land is intensifying rapidly. Kenneth Hermele has conducted field studies in Brazil, where sugar cane has been cultivated ...

Children evaluate educational games

2012-09-17

Is it possible to create suitable and amusing educational computer games? Can you use qualities from other types of games? And what do the children really think of these kinds of games? Wolmet Barendregt from The University of Gothenburg, conducts research on children's game playing, how we can support learning with design and include the children in the design process. And Wolmet Barendregt certainly involves the children very much in her research. During the Science Festival's school program in April this year, over a hundred preschool children attended a creative game ...

LAST 30 PRESS RELEASES:

Evaluating performance and agreement of coronary heart disease polygenic risk scores

Heart failure in zero gravity— external constraint and cardiac hemodynamics

Amid record year for dengue infections, new study finds climate change responsible for 19% of today’s rising dengue burden

New study finds air pollution increases inflammation primarily in patients with heart disease

AI finds undiagnosed liver disease in early stages

The American Society of Tropical Medicine and Hygiene and the Bill & Melinda Gates Foundation announce new research fellowship in malaria genomics in honor of professor Dominic Kwiatkowski