Methods for reducing the incidence of necrotizing enterocolitis

• US 6,306,908 B1
• Filed: 05/12/2000
• Issued: 10/23/2001
• Est. Priority Date: 02/21/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Dohnalek, Margaret H., Montalto, Michael B., Carlson, Susan E., Ponder, Debra L., Diodato, David V., Borror, David A., Benson, John D.
• Primary Examiner(s): Spivack, Phyllis G.
• Application Number:
  US09/570,299
• Time in Patent Office: 529 Days
• Field of Search: 514/560, 514/547, 514/78
• US Class Current: 514/560
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Enteral formulas that contain long-chain polyunsaturated fatty acids (PUFAs), e.g., arachidonic acid (AA), and docosahexaenoic acid (DHA), essentially free of cholesterol, are described for use in methods for reducing the incidence of necrotizing enterocolitis. Compositions from egg yolk lipids are preferred as they contain ω-6 and ω-3 long chain PUFAs and are predominantly in a phosphtidylcholine form. This is believed to provide a synergetic effect.

Claims

1. A method for reducing the incidence of necrotizing enterocolitis in an infant, said method comprising administering to an infant which is susceptible to necrotizing enterocolitis an effective amount of a composition comprising protein, carbohydrate and lipid, including at least 1.0 mg of ω

-6 polyunsaturated fatty acids per kg per day.

2. The method according to claim 1 wherein said at least one ω

-6 polyunsaturated fatty acid includes arachidonic acid.

3. The method according to claim 2 wherein said administration is performed enterally.

4. The method according to claim 2 wherein said administration is performed parenterally.

5. The method according to claim 4 wherein said parenterally administered composition comprises at least 20 mg of arachidonic acid per liter and at least 10 mg of docosahexaenoic acid per liter.

6. The method according to claim 5 wherein said parenterally administered composition comprises per liter about 20-200 mg of arachidonic acid and about 10-50 mg of docosahexaenoic acid.

7. The method according to claim 1 wherein said at least one ω

-6 polyunsaturated fatty acid is administered in combination with at least one ω

-3 polyunsaturated fatty acid.

8. The method according to claim 7 wherein said ω

-3 polyunsaturated fatty acid comprises docosahexaenoic acid.

9. The method according to claim 7 wherein said ω

-6 polyunsaturated fatty acid comprises arachidonic acid and said ω

-3 polyunsaturated fatty acid comprises docosahexaenoic acid.

10. The method according to claim, 9 wherein said administration is performed by feeding a sufficient amount of an enteral composition containing arachidonic acid and docosahexaenoic acid to deliver to said infant about 1.0 to about 60 mg per kg per day of arachidonic acid and about 0.25 to about 35 mg per kg per day of docosahexaenoic acid.

11. The method according to claim 10 wherein the weight ratio of arachidonic acid to docosahexaenoic acid ranges from about 2 to about 4.

12. The method according to claim 10 wherein the enteral composition additionally comprises vitamins and minerals.

13. The method according to claim 7 wherein said ω

-6 polyunsaturated fatty acid and said ω

-3 polyunsaturated fatty acid are long chain fatty acids independently selected from one or more sources selected from the group consisting of egg lecithin, fungal oils, algal oils and marine oils.

14. The method according to claim 7 wherein said ω

-6 polyunsaturated fatty acid and said ω

-3 polyunsaturated fatty acid are derived from genetically modified oil-bearing plants.

15. The method according to claim 7 wherein said ω

-6 polyunsaturated fatty acid and said ω

-3 polyunsaturated fatty acid are in the form of phospholipids.

16. The method according to claim 1 comprising feeding to an infant which is susceptible to necrotizing enterocolitis a sufficient amount of an enteral formula containing:

protein, carbohydrate and phospholipids, said phospholipids providing arachidonic acid and docosahexaenoic acid in concentrations to deliver to said infant from about 5 to about 40 mg per kg per day of arachidonic acid and from about 1.5 to about 20 mg per kg per day of docosahexaenoic acid, wherein the weight ratio of arachidonic acid to docosahexaenoic acid ranges from about 2 to about 4.

17. A method for providing nutrition to an infant susceptible to or having necrotizing enterocolitis, said method comprising enterally administering to said infant an effective amount of at least one ω

-6 polyunsaturated fatty acid in a nutritional matrix comprising protein, carbohydrate and fats, said matrix providing at least 1.0 mg of ω

-6 polyunsaturated fatty acids per kg per day.

18. The method according to claim 17 wherein said at least one ω

-6 polyunsaturated fatty acid includes arachidonic acid.

19. The method according to claim 17 wherein said at least one ω

-6 polyunsaturated fatty acid is administered in combination with at least one ω

-3 polyunsaturated fatty acid.

20. The method according to claim 19 wherein said ω

-3 polyunsaturated fatty acid comprises docosahexaenoic acid.

21. The method according to claim 19 wherein said ω

-6 polyunsaturated fatty acid comprises arachidonic acid and said ω

-3 polyunsaturated fatty acid comprises docosahexaenoic acid.

22. The method according to claim 21 wherein said administration is performed by feeding a sufficient amount of an enteral composition containing arachidonic acid and docosahexaenoic acid to deliver to said infant about 1.0 to about 60 mg per kg per day of arachidonic acid and about 0.25 to about 35 mg per kg per day of docosahexaenoic acid.

23. The method according to claim 22 wherein the weight ratio of arachidonic acid to docosahexaenoic acid ranges from about 2 to about 4.

24. The method according to claim 19 wherein said ω

-6 polyunsaturated fatty acid and said ω

-3 polyunsaturated fatty acid are long chain fatty acids independently selected from one or more sources selected from the group consisting of egg lecithin, fungal oils, algal oils and marine oils.

25. The method according to claim 19 wherein said ω

-6 polyunsaturated fatty acid and said ω

-3 polyunsaturated fatty acid are in the form of phospholipids.

26. The method according to claim 17 comprising feeding to an infant which is susceptible to necrotizing enterocolitis a sufficient amount of an enteral formula containing:

protein, carbohydrate and lipids, said lipids providing arachidonic acid and docosahexaenoic acid in concentrations to deliver to said infant from about 5 to about 40 mg per kg per day of arachidonic acid and from about 1.5 to about 20 mg per kg per day of docosahexaenoic acid, wherein the weight ratio of arachidonic acid to docosahexaenoic acid ranges from about 2 to about 4.

27. The method according to claim 17 wherein said nutritional matrix further comprises vitamins and minerals.