The US Food and Drug Administration (FDA) has given Mead Johnson Nutritionals clearance to introduce a third product in the Enfamil Lipil line.
The Enfamil EnfaCare Lipil infant formula contains DHA and ARA, two nutrients found naturally in breast milk, which are essential for healthy development of the brain and eyes.
This DHA and ARA blend has been called Lipil. The new formula is for premature infants who have left the hospital, but still require the extra calories, nutrients and minerals of a specialised formula. EnfaCare Lipil has been clinically demonstrated to support growth and development in premature infants, said the company.
"The rate of premature births is on the rise in the US, going from 9.8 per cent of all births in 1985 to about 12 per cent today," said Dr J. Roberto Moran, vice president and medical director for Mead Johnson Nutritionals.
"Studies have shown that receiving the nutrients DHA and ARA at the levels and ratio found in both Enfamil Premature Lipil (introduced earlier this year) and new EnfaCare Lipil can significantly enhance the growth and development of pre-term infants."
Mead Johnson, owned by BristolMyersSquibb, cited two large studies that have shown significant improvements in growth and development in premature infants fed formula supplemented with Lipil.
"We compared premature infants who consumed Enfamil formulas with Lipil, including Enfamil Premature Lipil and EnfaCare Lipil, with premature infants consuming the same formulas without DHA/ARA, and we saw measurable differences," said Dr Thomas Clandinin from the University of Alberta, Edmonton.
"The infants getting the supplemented formula had higher scores on development tests and they gained in weight and length more rapidly."
In the study led by Dr Clandinin and presented at the May 2002 Pediatric Academic Societies' Annual Meeting, very-low-birth-weight premature infants fed Enfamil formulas with Lipil, including Enfamil Premature Lipil and EnfaCare Lipil, actually caught up in weight to a reference group of breastfed term infants by approximately 18 months of age and caught up in length by 9 months corrected age.
Infants fed the same formulas without Lipil grew more slowly. In addition, the infants receiving Enfamil formulas with Lipil scored higher on tests of development at 18 months compared to the infants fed the control formulas. "This is yet an additional study that demonstrates the safety and nutritional benefits of Enfamil formulas with Lipil," said Moran.
Another study, published in the May 2002 issue of The Journal of Pediatrics and led by Dr Sheila Innis from the University of British Columbia, Vancouver, also found positive effects on weight gain in premature infants fed Enfamil Premature Lipil. This study compared very-low-birth- weight infants who were given Enfamil Premature Lipil for at least 28 days during hospitalisation to very-low-birth-weight infants given the same premature formula with no DHA and ARA. The infants who consumed Enfamil Premature Lipil gained weight significantly faster during hospitalisation than the infants who consumed the same formula without Lipil, and had weights and weight to length ratios comparable to those of term breast-fed infants when measured at 2 and 4 months corrected age.
EnfaCare Lipil will be available in the US later in the year. Enfamil Lipil for full-term infants and Enfamil Premature Lipil are currently available in the US.