1. KIMBERLY MANNEBACH RD,CSP,LD OCTOBER 20, 2014 Thoughtfully Navigating the Formula Market

2. Disclosures None

3. Infant Feeding

4. The Ideal - Breastfeeding Breast milk  Protein – whey:casein is 60:40 to 70:30  Decreases in concentration first 2 months of lactation  Carbohydrate – lactose  Most variable nutrient – higher concentrations when higher volumes produced  Fat – high in palmitic and oleic acids  Variable due to diet. US diet makes it high in LCPUFAs and low in DHA  AND all that great other stuff. Morrow et. Al Pediatr Clin North Am. 2013 February: 60(1): 49-74

5. Bioactives of Breast milk Macrophages – protect against infection Stem cells – regenerate and repair IgA – pathogen binding inhibition IgG – anti-microbial IgM – complement activation Cytokines  IL-6 – stimulates acute phase responses  IL-8 – recruits neutrophils  IL-10 – induces antibody production Growth factors  EGF – stimulates cell proliferation and maturation  IGF – stimulates growth, increased RBS and hemoglobin  HB-EGF – protective against damage from hypoxia and ischemia  Erythropoietin – intestinal development Hormone somatostatin – regulates gastric epithelial growth Lactoferrin – chelates iron, anti bacterial, antioxidant Leptin – regulates energy conversion, appetite regulation Ghrelin – regulates energy conversion and infant BMI Oligosaccharides  HMOS – prebiotic for beneficial colonization of gut  Gangliosides – brain development Morrow et. Al Pediatr Clin North Am. 2013 February: 60(1): 49-74

6. My client isn’t breastfeeding, now what? Enfamil Infant  Protein – whey:casein 60:40  Carbohydrate – lactose  Fat – palm olein, coconut, soy and high oleic sunflower oils  Other goodies:  DHA/ARA (0.32% fatty acids to match breast milk)  Dual prebiotics – GOS (galactooligosaccharides) & polydextrose GOS feeds top part of bowel Polydextrose feeds lower part of bowel Synthetic polymer of glucose classified soluble fiber by USDA but generally used to replace sugar in sugar free foods or increase fiber in foods.

7. Similac Advance Protein – whey:casein 48:52 Carbohydrate – lactose Fat – high oleic safflower, coconut, soy The other goodies:  Prebiotic – GOS  DHA  Natural vitamin E for improved absorption  Lutein – increases carotenoids in brain for learning, intentionally added vs. other formulas have trace amounts  Lutein and vitamin E protect DHA from being oxidized by free radicals so higher amount absorbed

8. Similac for Supplementation Similac Advance formulation with an increase in amount of prebiotics to help give looser “breast fed baby” stools.

9. Why is Similac now 19 kcal/oz? Breast milk banking has allowed increased analysis of caloric contents in breast milk.  Researchers found range of 18.4-19.3  IOM and European Commission found 19.2-19.3  AAP found range to be 18.6-21 Done in Europe previously without issue Not USDA approved so only applies to non WIC packaged formulas (plastic square containers) Decreased slightly all 3 macronutrients Alimentum and Neosure unchanged.

10. I’ve heard some things about palm olein oil… Predominant fat in Enfamil products When combined with soy oil makes ratio of palmitic and oleic acids similar to breast milk. 2 studies:  Koo et al., Reduced bone mineralization in infant fed palm olein containing formula. Pediatrics. 2003 May.  Young et al., Neonatal and infant feeding: Effect of bond density at 4 years. Journal of Pediatric Gastroenterolgoy and Nutrition. 2005 July. Palm olein oil decreases absorption of calcium by binding calcium to unabsorbed palmitic acid which also creates insoluble calcium soaps and can worsen constipation.

11. DHA/ARA Long chain polyunsaturated fatty acids (LCPUFA) DHA  22 carbon chain  Key for development of structure and function of neural tissues specifically retina and brain (grey matter)  Can be derived from alpha-linolenic acid ARA  20 carbon chain  Key cell membrane component  Synthesized from linoleic acid Is they synthetic DHA/ARA used in formula safe?  Tests have proven no levels of hexane in formula however no true research completed.

12. Enfamil Reguline Designed for constipated babies.  Partially hydrolyzed protein  Dual prebiotics – GOS and polydextrose  1.5mg/100kcal instead of 1.8mg (not low iron but low end of mandated range) Should not be used if baby gassy as prebiotics could worsen. Continues to have DHA and choline for development equivalent to Enfamil Infant.

13. Soy Formulas Enfamil Prosobee or Similac Soy Isomil Milk and lactose free – corn syrup solids for carbohydrate To be used for patients with lactose deficiency or intolerance or those wishing to maintain vegetarian lifestyle. Marketed towards fussiness and gas. Over used compared to number of people in US with true lactose intolerance. NIH Nat’l Institute of Environmental Health Sciences reviewed research on soy and hormonal changes found in animal studies.  Found minimal concern for adverse affects of soy formula

14. Enfamil Gentlease Designed to improve fussiness and gas  Partially broken down proteins with 60:40 whey:casein ratio  20% carbohydrates from lactose Can sometimes be enough to help refluxing baby also.

15. Total Comfort vs. Sensitive Similac Total Comfort  Marketed to discomfort from persistent feeding issues.  Partially hydrolyzed whey proteins. Similac Sensitive  Marketed to fussiness and gas.  Reduced lactose for mild intolerance symptoms.

16. Added Rice formulas Enfamil AR  Marketed to spit up or reflux babies.  AR = added rice starch  Increases viscosity without thickening through nipple. Similac for Spit-Up  Marketed to spit up or reflux babies.  Reduced lactose with added rice starch. *These formulas only work in patient isn’t on medications for reflux. (ranitidine or prevacid)

17. Does adding rice to bottles help reflux? Quick answer – we don’t think so.  No evidenced based research confirms rice cereal helps. Issues with adding:  Very high in carbohydrates/calories once added  Rice cereal is 15kcal/T which makes 20kcal/oz formula ~30kcal/oz  Makes distribution of fat, protein and carbs wrong so possibly will increase fat stores due to high carb diet.  Asking infant intestines to digest something it shouldn’t be to digest yet.

18. What about the corn syrup? Corn syrup solids are main carbohydrate used in formulas when lactose removed  Ex: Gentlease, Spit-Up, Sensative Corn syrup solids not equivalent to high fructose corn syrup. International Formula Council statement So what are corn syrup solids?  Deyhdrated corn syrup to powder form  Primary sugar is dextrose which is ¾ as sweet as sugar HFCS sweeter than cane sugar and more processed than corn syrup solids.

19. Formulas for Patients with Allergies Nutramigen (Enflora LGG)  Extensively hydrolyzed proteins for those allergic to intact cow or soy protein  Lactose free  Powder contains probiotic LGG – liquid does not.  Does not contain dual prebiotics.  Marketed to allergies or colic  Osmolality 300 Expert Care Alimentum  Hydrolyzed casein plus free amino acids  Lactose free  RTF is corn free  33% fat as MCT for improved fat absorption  Does not contain prebiotics  Marketed to allergies, colic and fat malabsorption  Osmolality 370

20. Formulas for Patients with Allergies Pregestimil  Marketed to patients with fat malabsorption who are also sensitive to intact proteins.  Ex: CF, short bowel syndrome, intractable diarrhea  Lactose free  Does not contain prebiotics  55% fat as MCT  Osmolality 320 *24kcal would be excellent formula for CF population.

21. Formulas for Severe Allergies - $$$$ PurAmino (Nutramigen AA)  Hypoallergenic – protein down to amino acids  Can be used up to 24 months  Osmolality 350 Neocate Infant  Made by Nutricia, predominately European company.  Hypoallergenic  45 clinic trials to back  No palm olein oil  Can use for severe milk/soy allergy, SBS, EE, malabsorption  Osmolality 375

22. Formulas for Severe Allergies - $$$$ Elecare  Hypoallergenic to be used for protein maldigestion, malabsorption, severe food allergies, SBS, EE  33% fat as MCT  Lactose free  Osmolality 350

23. Preterm Formulas – Discharge Formulas Should be used on any patient born before 37 weeks GA AAP recommends continuation until 6-12 months corrected age Can’t base changing to term formula on wt-for-ln as weight catches up faster than height.  Extra nutrients of formula needed to catch up height otherwise nutritionally shunted patients growth. Can be used in combination with breastfeeding upon discharge.  2-3 formula bottles/day if supply not adequate  Use as “fortifier” in expressed breast milk.  24kcal/oz - 70mL breast milk: 1tsp powder Commercially prepared human milk fortifier is for in hospital use only. Request for it should be red flag.

24. Preterm Infants – Discharge Formulas Enfacare  22kcal/oz to help with catch up growth  2.8g/100 cal protein vs. 2.1g  120mg Calcium vs. 78mg  66mg Phos vs. 43mg  Same levels of DHA, ARA, omega 6 and 3 and Infant  20% fat as MCT Neosure  22kcal/oz  If used until 12mo showed sig increase in body mass w/ less fat mass than preterm babies fed term formula (Groh-Wargo 2005)  2.8g Pro vs 2.07g  105mg Calcium vs 78mg  62mg Phos vs 42mg  25% fat as MCT  DHA, ARA and Lutein

25. Preterm – Hospital Use Formulas Enfamil Premature and Similac Special Care  Comes in 20, 24 and 30kcal/oz 2oz nursettes as designed to mix any calorie level needed in NICU  24 + 30 = 27kcal/oz  No lactose as lactase enzyme not mature until >34 weeks.  Why high protein?  Protein needs of up to 4-5g/kg in preterm infants. New research showing high protein more important than high calorie intakes.  General NICU population should not come home with one of these formulas.  Possibly used for BPD or other fluid restriction if other formulas not tolerated.

26. The other guys… Enfamil 24kcal/oz  Used for cardiac patients with increased needs and fluid restriction or FTT patient that family not able to mix reliably. Enfaport  84% fat as MCT for chylothorax patients.  0-12 months Monogen  90% fat MCT for chylothorax or other lymphatic disorders.  >1 year old

27. The rest of the other guys… RCF  Carbohydrate free formula for seizure disorders requiring Ketogenic diet  Designed for infants. Calcilo XD – low Ca & vit. D free  Abbott product  Used for hypercalcemia due to Williams syndrome or neonatal hyperparathyroidism PM 60/40  For patient with renal dysfunction requiring low mineral intake  Ca:Phos designed to manage serum calcium disorders  Low iron – if required may need supplement

28. Pediatric Formulas

29. Toddler Formulas Enfagrow Transitions  Gentlease  Soy Nutramigen with Enflora Toddler Should not be used if toddler/pediatric formula needed in long term. Nutramigen and Gentlease may be used as work to find milk source that patient will tolerate well. If patient table food intake not age appropriate may help balance diet. Comparable calories to whole milk.

30. Pediasure & Boost Kids Essentials 30kcal/oz Nutritionally completed for 1-8 yo at 1000mL and 9-13 yo 1500mL If 100% formula intake recommend fiber If used as supplement recommend no more than 50% needs for age to encourage eating.  Can also encourage eating by using as snacks rather than around meal time. Is there a difference between enteral and oral?  Yes – less sweetened/flavored so osmolality difference of ~130  Enteral can be good for 1 year old as less sweet when not yet used to strongly sweetened foods. Can you switch from brand to brand or fiber to no fiber?  Many children yes however some kids are definite no. Family typically knows if tried and tolerated vs. not.

31. Compleat Pediatric Made from real food ingredients including chicken, fruit, vegetables and cranberry juice. May good for child who has feeding intolerance of unknown cause – especially those with developmental disabilities. 30kcal/oz – nutritionally complete Contains Nutrisource Fiber – soluble fiber to help with regular bowel functions.

32. Higher Calorie Formulas BKE and Pediasure 1.5  Can be used for extremely underweight/increased needs, volume limitations or fluid restrictions.  Use with caution as oral supplement unless significantly behind in growth as can fill up to point that patient doesn’t eat anything as little as 2 cans/day. Nutren 2.0  Adult formula typically for those >13 years but may use in special circumstances younger  Used highly by CF patients especially those with Gtubes to get large amounts of calories in low volume so not too filling.

33. Reduced Calorie Formulas Compleat Pediatric Reduced Calorie Pediasure Sidekicks 0.6kcal/mL Used for patients with especially low calorie needs or those needing low calorie oral supplements.  Cerebal Palsy  HIE  Oral aversion to certain food groups

34. Bright Beginnings Soy Soy based supplement for 1-13 years of age 30kcal/oz Nutritionally complete If infant required soy formula typically will retest with standard formula before beginning unless allergy testing confirms.

35. Peptide Based Formulas Peptamen Junior  Available in 1 and 1.5  100% hydrolyzed whey protein – thought to improve gastric emptying rates  60:40 MCT:LCT ratio  With Prebio has FOS and inulin added Pediasure Peptide  Available in 1 and 1.5  100% hydrolyzed with 70:30 whey:casein  60% fat structured lipids  Middle molecule on TG backbone LCT to sneak into MCT absorption  50:50 MCT:LCT ratio  Prebiotic scFOS (short chain fructo- oligosaccharides)

36. Elemental Formulas Elecare Junior  Designed for >1 year  100% free amino acids  33% fat as MCT  Powder so flexibility in calorie concentrations mixed.  Osmolality 590 Neocate Junior  For children 1-10  High protein for GI tissue repair  Higher micronutrients for malabsorptive conditions  35% fat as MCT  Available with Prebiotics of FOS and inulin  Powder so flexibility in calorie concentrations mixed  Osmolality 570

37. Elemental Formulas Vivonex Pediatric  Available powder packets or RTF  Lower osmolality at 360 compared to Neocate and Elecare Neocate Splash (EO28)  Clear – grape, tropical or orange  100% free amino acids  Good for oral supplement for children with severe allergies.

38. The other guys…. Boost Breeze  Clear supplement for children that refuse milk like texture of other supplements  Especially accepted by patients with autism Ketocal 3:1 or 4:1  Ratio = fat gm: carb+pro gms  Used for children with seizure disorders, epilepsy, pyruvate dehydrogenase deficiency requiring Ketogenic diet Portagen  Not nutritionally complete  Used for children and adults with defective lymphatic system, decreased pancreatic lipase or bile salts or defective mucosal fat absorption  87% fat as MCT

39. And more of the other guys… Suplena  Designed for people with stage 3 or 4 CKD  Can be complete source of nutrition or supplement Duocal  Fat and carbohydrate only nutrition powder  Helpful to add calories when unable to add more protein  25kcal/scoop  May be mixed into food or formulas  Use regularly for cardiac condition infants needing >30kcal/oz formula or children not growing that prefer low calorie foods

40. Questions?

41. Thank you!