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Method of reducing the risk of retinopathy of prematurity in preterm infantsRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Food Or Edible As Carrier For PharmaceuticalMethod of reducing the risk of retinopathy of prematurity in preterm infants description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070166354, Method of reducing the risk of retinopathy of prematurity in preterm infants. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a continuation-in-part of U.S. Patent Application No. 11/584,704, filed Oct. 20, 2006, which makes reference to and claims the benefit of U.S. Provisional Patent Application 60/730,283 filed Oct. 26, 2005. TECHNICAL FIELD [0002] The present invention relates to infant formulas and methods for using those formulas to promote retinal health and vision development in infants, including reducing the severity or risk of retinopathy of prematurity. BACKGROUND OF THE INVENTION [0003] Infant formulas are commonly used today to provide supplemental or sole source nutrition early in life. These formulas contain protein, carbohydrate, fat, vitamins, minerals, and other nutrients. They are commercially available as powders, ready-to-feed liquids, and liquid concentrates. [0004] Although many infant formulas provide a quality alternative to human milk, they still do not provide the same high level of nutrition as found in human milk As such, much of the research effort into infant formulas over the past several years has been directed to better understanding the natural constituents of human milk, and then modifying infant formulas accordingly, or at least to the extent possible with currently available technology. [0005] Arachidonic acid and docosahexaenoic acid, for example, have been identified in human milk and subsequently added to synthetic infant formulas. These fatty acids support brain and vision development in infants, and are now commonly found in commercially available formulas such as Similac.RTM. Advance.RTM. Infant Formula, Isomil.RTM. Advance.RTM. Infant formula, and Similac.RTM. Special Care.RTM. Advance.RTM. infant formula, all of which are available from Ross Products Division, Abbott Laboratories, Columbus, Ohio, USA. [0006] Lutein has also been identified in human milk Although it is not currently added to infant formulas as an isolated ingredient, lutein can be found at low concentrations in infant formulas as an inherent ingredient in some of the natural oils commonly used make such formulas. Lutein is an antioxidant that also happens to concentrate within the retina of the eye. It is generally known that dietary lutein may provide individuals with eye health benefits, and it is speculated that such benefits may be extended to infants receiving lutein from either human milk or supplemented infant formula [0007] It is now believed that a combination of lutein and docosahexaenoic acid may be particularly important in promoting retinal health and vision development in infants. Both materials are present in human milk and both are known to concentrate in the retina in otherwise healthy subjects. Docosahexaenoic acid (DHA), as a polyunsaturated fatty acid, is highly susceptible to damage by oxidation and degradation within the eye, while lutein is a known antioxidant It is believed that by adding lutein to infant formulas, not only will it concentrate within the retina, it may also reduce oxidative degradation of the retinal DHA and thus further promote retinal health and vision development in the infant [0008] It has now been found, however, that lutein concentrations in infant formula must be much higher than the lutein concentrations found in human milk in order to achieve the same plasma lutein concentrations found in breast fed infants due to a lower relative bioavailability of lutein from infant formula Although infant formulas today typically contain less than about 20 mcg/liter of lutein, most of which comes inherently from added fats and oils, it has now been found that such lutein concentrations must exceed about 50 mcg/liter, preferably from about 100 mcg/liter to about 200 mcg/liter, in order to duplicate plasma lutein concentrations found in exclusively in breast fed infants. [0009] Consequently, it has also been found that infant formulas containing combinations of lutein and DHA, as described above, should now be formulated with higher ratios (lutein to DHA) than are commonly found in human milk. These weight ratios of lutein (mcg) to DHA (mg) should now range from about 1:2 to about 10:1. [0010] It has also been found that the severity or risk of retinopathy of prematurity (ROP) is influenced by skin carotenoid levels found in preterm infants fed human milk This finding suggests that preterm infants can be monitored for skin carotenoid concentrations, and then for those infants demonstrating low skin carotenoid levels, supplemental carotenoids may be administered in amounts sufficient to increase skin carotenoid levels, to thus reduce the risk or severity of retinopathy of prematurity. SUMMARY OF THE INVENTION [0011] A first embodiment is a method of reducing the risk or severity of retinopathy of prematurity in preterm infants. The method comprises (a) measuring skin carotenoid levels in preterm infants, preferably by Raman Spectroscopy, and then (b) administering supplemental carotenoids to those infants in need thereof, wherein the supplemental carotenoids comprise lutein, lycopene, beta arotene, and zeaxanthin. The supplemental carotenoids may be provided by an infant formula comprising, on a ready-to-feed basis, from about 100 to about 2000 mcg/liter of total carotenoids, wherein the total carotenoids include at least about 50 mcg/liter of lutein. [0012] The supplemental carotenoids may also be administered as a preterm infant formula comprising fat, protein, carbohydrate, vitamins, and minerals. The infant formula may further comprise docosahexaenoic acid in a weight ratio of lutein (mcg) to docosahexaenoic acid (mg) of from about 1:2 to about 10:1. [0013] It has been found that the severity or risk of retinopathy of prematurity (ROP) is influenced by skin carotenoid levels found in preterm infants fed human milk. This finding suggests that skin carotenoid levels may be monitored in preterm infants, and then administered to those infants in need thereof to reduce the risk or severity of retinopathy of prematurity. [0014] It has been found that infant formulas may be prepared with lutein concentrations of at least 50 mcg/liter if they are to produce the same plasma lutein concentrations found in breast fed infants, even though human milk itself typically contains no more than about 30 mcg/liter of lutein. It has also been found, consequently, that the weight ratio of lutein (mcg) to DHA (mg) in an infant formula may range from about 1:2 to about 10:1. It is believed that the combination of lutein and docosahexaenoic acid are particularly useful in promoting retinal health and vision development in infants, provided that sufficient quantities of each are designed into the infant formula as described herein. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a graph of lutein intake (mcg/day) and corresponding plasma lutein concentrations (mcg/dl) in infant groups fed human milk (HM) or infant formulas containing varied concentrations of lutein [CTRL with 14.6 mcg lutein/liter (no added lutein, all lutein inherent in ingredients)]; L1 with 32.6 mcg lutein/liter (approximately 18 mcg/liter added lutein, remainder inherent), L2 with 52.6 mcg lutein/liter (approximately 38 mcg/liter added lutein, remainder inherent). [0016] FIG. 2 is a graph showing visual acuity as measured by sweep visual evoked potential (logMAR) in monkeys at 4, 8, and 12 weeks of age. The monkeys are fed infant formula with either DHA and added lutein (n=8) or DHA without added lutein (n-8) during a 12 week feeding period. DETAILED DESCRIPTION OF THE INVENTION [0017] The present invention, including essential and some optional features or limitations, is described hereinafter in detail. [0018] The terms "infant" and "preterm infant" as used herein, unless otherwise specified, are used interchangeably to mean preterm infants born at less than about 37 weeks gestation, typically from about 26 to about 34 weeks gestation, and or low birth weight infants (term or preterm) at less than 2.5 kg at birth, including those less than 1.8 kg at birth. Continue reading about Method of reducing the risk of retinopathy of prematurity in preterm infants... 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