1. Infant Formulas What’s for What and What’s for Whom???

2. Infant Formula
Product intended for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk

3. Historical Perspective
Early attempts at artificial feeding of infants employed the milk of other mammals
Infant survival during the 1st few weeks of life approached 0%
Wet nurses were employed but their availability declined with the onset of the Industrial Revolution

4. Examples of Early Infant Feeding Vessels
Pewter
Ceramic

5. Commercial Formula Development
In 1867, Henri Nestlé created the first commercially sold formula.
Banana feeder

6. At the end of the 19th century the gross composition of human milk was determined.
Recognition of low concentration of protein in BM lead to the use of diluted cow milk
Less mortality among infants
But poor growth
To increase caloric density of diluted cow milk, sugar or cereals were added
Infants lived and grew
Pediatrics became a medical specialty
Mortality still remained high

8. Early 20th century Electric refrigeration and pasteurization
Significant decrease in mortality
Increased popularity of formula feeding
Improved sanitation and milk handling
Modifications in cow protein improved digestibility
Direct advertising to physicians influenced use of formulas

9. Good rubber nipples made feeding easier

10. 1911-- Dextri-Maltose introduced by Mead Johnson
a formula called synthetic milk adapted (forerunner of Wyeth’s SMA) required only the addition of water
67 kcal/dL
Non-fat cow milk
Lactose
Oleo and vegetable fat

11. The importance of vitamins was recognized
Infant formulas became suitable vehicles
Previously common vitamin-deficiency diseases such as scurvy and rickets became less prevalent

12. Highlights in Formula History
1929--the first soy flour formula was developed
milk–free, lactose–free
designed as an alternative to the home prepared milk–based formulas of the time
soy flour caused significant abd discomfort
1942--protein hydrolysate formula
1959—iron-fortified formula appeared
1960—appreciation of renal solute load
1965--soy protein isolate formula

13. 1966—1st premmie formula designed to meet the special nutritional needs of rapidly growing low–birth–weight infants.
1971--first nutritionally complete protein hydrolysate formula containing MCT oil.
1990’s
lactose free cow milk-based formulas appeared
Nucleotides were added to some formulas
Early 2000’s
DHA and ARA were added to both cow milk and soy formulas

14. Infant Formula Act Passed by Congress in 1980
Following reports in 1979 that over 100 infants became seriously ill because of the lack of chloride in two soy-based formulas
The new law authorized the FDA to adjust nutritional standards for infant foods to conform with the best available scientific knowledge.
Manufacturers are required to test their products periodically and report to the FDA when they do not meet the official specs.

15. Furthermore….Formula Manufacturers are required to
Verify composition before a new product goes to market
specifying that it meets minimum (29 nutrients) and does not exceed maximum (9 nutrients) requirements
Meet “good manufacturing practices”
Maintain records for annual inspection
The FDA has the authority to recall products that are adulterated or misbranded

16. The types of formula feeding:
A-Complementary feeding: (each feed) breast is given 1st until it is emptied then formula is given to complete the feeding.
B- Supplementary feeding: formula is given to substitute one or more feeds.
C-Substitutive feeding: no breast feeding ,formula only.

17. Forms of formula:
Formulas come in three basic forms:
1-Ready-to-use formula no mixing or measuring required, just open and serve recycle all of the cans or bottles.
Once opened, it must be used within 48 hours.
2-Liquid concentrate formula requires you to mix equal parts of water and formula, so read the instructions on the container carefully.
3-Powdered formula. is the most economical choice, and you must follow the directions exactly, but it has a one-month shelf life after the container has been opened.

18. Types of formula
There's a formula to suit every baby's needs.
1-Cow's-milk-based formula: Most formula available 2-Soy-based formula: If the baby has trouble digesting cow's milk protein
3-Lactose-free formula: If the baby is lactose-intolerant, or unable to digest lactose.The doctor may suggest this formula if the baby has colic.

19. 4-Extensively hydrolyzed formula: In these formulas, the protein is broken down into smaller parts that are easier for the baby to digest than larger protein molecules. The baby may need a hydrolyzed formula if he has allergies or trouble absorbing nutrients. The doctor may also suggest trying a hydrolyzed formula if the baby has colic. 5-Formulas for *premature and* low-birth-weight babies: These formulas often contain more calories and protein.

20. 6-Human milk fortifier: This product is used to enrich the nutrition of breastfed babies who have special needs. Some are designed to be mixed with breast milk, and some can also be fed alternately with breast milk. 7- Iron Fortification :The American Academy of Pediatrics discourages use of low-iron formulas. Proper level of iron-fortification is necessary for normal infant growth and cognitive development.
The parents should discuss this option with the baby's doctor.

21. Categories of Infant formulas
Standard
Similac, Enfamil, Carnation, Store brands
Soy
Isomil, Prosobee, Alsoy,
Protein hydrolysates
Pregestimil, Nutramigen, Alimentum
Elemental
Neocate, Elecare
Premature
Enfacare, NeoSure
“Next Step”—older infants and toddlers
Specialized
Modified for specific medical indication
Metabolic, renal, GI disorders

22. Standard Formulas Cow milk altered by Whey to casein ratio varies
Removing the butter fat
Adding vegetable oils and carbohydrate
Decreasing the protein
34 g/L to 15 g/L
Adding vitamins, minerals, and other nutrients such as amino acids, fatty acids, nucleotides
Whey to casein ratio varies
Major whey protein is β-lactoglobulin
Major casein protein is bovine -casein
Amino acid profile varies
Taurine and carnitine are added to some

23. Whey to Casein Ratio % Whey % Casein Breast milk 70 30 β-casein
-lactalbumin, lactoferrin, IgA 30
β-casein
Enfamil 60 40
Similac 18 82
Carnation
Good Start
100
Soy

24. Standard Formula Features
Breast milk
20cal/oz
Human milk fat
Lactose
whey:casein 70:30
9 g/L
Iron 0.3mg/L
Vitamin D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
Infant formula
20cal/oz
Soy, coconut, sunflower, palm
Lactose
60:40, 18:82
 15 g/L
Iron 12mg/L
Vitamin D 405 IU/L
mOsm/kg H20
DHA and AA added
Formulas still made without

25. Low Iron Formula
PEDIATRICS Vol. 104 No. 1 July 1999, pp
AMERICAN ACADEMY OF PEDIATRICS: Iron Fortification of Infant Formulas
Position Statement
“The manufacture of formulas with iron concentrations less than 4.0 mg/L should be discontinued. If these formulas continue to be made, low-iron formulas should be prominently labeled as potentially nutritionally inadequate with a warning specifying the risk of iron deficiency. These formulas should not be used to treat colic, constipation, cramps, or gastroesophageal reflux.”

26. Soy Formulas Indications for use Not appropriate for
Milk protein intolerance (IGE mediated)
Lactose intolerance (rare)
Galactosemia
Vegetarian diet
Not appropriate for
preterm infants < 1800 grams d/t risk of osteopenia and growth concerns
Hereditary fructose intolerance (contains sucrose)

27. Soy Formulas Breast milk formula 20cal/oz 20cal/oz Human milk fat
Lactose
whey:casein 70:30
9 g/L
Iron 0.3mg/L
Vitamin D 21IU/L
260 mOsm/kg H20
Contains DHA and AA
formula
20cal/oz
palm olein, soy,coconut,sunflower
Corn syrup/sucrose
Protein, 17 g/L soy isolate and L-MET
Iron 12mg/L
Vitamin D 405 IU/L
200 mOsm/kg H20
DHA and AA added
There should not be a low-iron formula on the market for the average child because a low-iron formula is a nutritionally deficient formula," says Klish. "It doesn't provide enough iron to maintain proper blood cell counts or proper hemoglobin." (Hemoglobin is a blood protein that carries oxygen from the lungs to the tissues, and carbon dioxide from the tissues to the lungs.)
In addition, studies have shown that school children who had good iron status as infants because they were fed iron-fortified formula performed better on standardized developmental tests than children with poor iron status. However, FDA has permitted marketing of low-iron formulas because some pediatricians prefer to use them.
Why is there low-iron formula on the market? "In the past there have been a lot of symptoms that have been attributed to iron, including abdominal discomfort, constipation, diarrhea, colic, and irritability," says Klish. "Also there was some concern about too much iron interfering with the immune system. All of those concerns and questions have been laid to rest with appropriate studies."
Another reason for originally producing low-iron formulas was that human milk contains low amounts of iron--less than a milligram per liter. However, it is now understood that an infant absorbs virtually 100 percent of the iron from human milk, but considerably less from infant formula.

28. Protein Hydrolysates Hydrolyzed casein or whey protein
Various fat blends
All are lactose free

29. Protein Hydrolysates Breast milk Pregestimil 20cal/oz Human milk fat
MCT (55%), safflower, soy
corn syrup solids, corn starch
Casein Hydrolysate-nonantigenic peptides
19 g/L
Iron 12mg/L
Vitamin D 405 IU/L
330 mOms/kg H20
Does not have DHA and AA
Breast milk
20cal/oz
Human milk fat
Lactose
70%whey 30%casein
9 g/L
Iron 0.3mg/L
Vit D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA

30. Other Hydrolysates Alimentum Advance Nutramigen LIPIL
For infants and children with severe food allergies, sensitivity to intact protein (including colic symptoms due to protein sensitivity), protein maldigestion or fat malabsorption
Hydrolyzed casein + free amino acids
33% of fat is MCT
370 mOms/kg H20
Contains DHA and ARA
Lactose free (contains sucrose)
Nutramigen LIPIL
hypoallergenic
for infants who are sensitive to intact protein in milk and soy-based formulas
270 mOms/kg H20
Lactose and sucrose free

31. Enfamil Gentlease LIPIL
Launched in July 05
“is a nutritionally balanced, milk-based infant formula designed as a first switch formula for babies who have fussiness or gas.”
Partially broken down proteins
6-9% hydrolyzed
Reduced lactose
1/4 of typical
Whey:casein ratio of 60:40
Contains DHA and ARA, “nutrients also found in breast milk that promote brain and eye development.”
No studies to document efficacy in the intended population

32. Elemental Formulas
Indications: For infants and children who need an amino acid-based medical food or who cannot tolerate intact protein
protein maldigestion or malabsorption
Short bowel syndrome
severe or multiple food allergies
GI tract impairment
eosinophilic esophagitis or gastroenteritis
Lactose, sucrose, fructose, and galactose-free
Galactosemia and hereditary fructose intolerance

33. Elemental Breast milk Neocate/Elecare 20cal/oz 20cal/oz Human milk fat
Lactose
70%whey 30%casein
9 g/L
Iron 0.3mg/L
Vit D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
Neocate/Elecare
20cal/oz
MCT, safflower, soy
Corn syrup solids
100% free amino acids, 21 g/L
Iron 12mg/L
Vitamin D 500 IU/L
335 mOsm/kg H20
Do not contain DHA and AA

34. Premature Formulas NICU Similac Special Care Enfamil Premature Lipil
20 and 24 kcal/oz
Available only for inpatients
Cow milk based
40% of fat is MCT
Products are not appropriate for larger babies (2.5-3 kg) because of higher amounts of vitamins (esp A and D) and minerals

35. Premature Infants Hospital discharge Improved growth NeoSure EnfaCare
22 kcal/oz
 Pro, calcium, phosphorus, MCT (20%)
Cow milk based
Improved growth
Wheeler, RE. Journal of Perinatology, 16: , 1996.

36. Specialized Portagen RCF Ross Carbohydrate Free
86% MCT oil fat malabsorption, intestinal lymphatic obstruction, or chylothorax
2002 recall after the death of a premature infant from Enterbacter sakazakii contaminated formula.
Manufacturer no longer recommends for infants
RCF Ross Carbohydrate Free
Infants with CHO intolerance
Must add CHO
Modified for the ketogenic diet

37. Specialized, cont: Similac PM 60/40 Metabolic Formulas
For infants with hypocalcemia due to hyperphosphatemia or impaired renal function.
Metabolic Formulas
PKU, MSUD, tyrosinemia, homocystinuria, glutaric aciduria, PPA/MMA, urea cycle
Ross, Mead Johnson, Scientific Hospital Supplies

38. Toddler Formulas Milk and soy based products for infants and toddlers
9-24 months
who are eating solid foods
Contain DHA and ARA
Has > twice the calcium of regular infant formulas (300 mg vs 125 mg)

39. Alternatives to Infant Formulas
Evaporated Milk Formula
AAP does not support its use
Poorly digested fat
Low iron and vitamin C
Excessive sodium, protein, PO4
Preferable to unmodified cow milk
Recipe
13 oz can
19.5 oz water
3 Tablespoons sugar or corn syrup
Requires supplementation with vitamins A, D, calcium, and iron

40. Case 10.5 mo old female with hx of poor growth 7.5 mo corrected age
26.5 weeks gestation
3 mo NICU course complicated by poor feeding, BPD, hernia repair, seizures
Discharged on Elecare and O2
7.5 mo corrected age
Meds—synthroid, zantac, Poly-vi-sol, flovent, calcium gluconate

41. Weight--5 kg
Length cm
IBW--6.5 kg
77% of IBW

42. Dietary data 24-hr dietary intake
Family had switched to goat milk 1 mo prior on the advice of “someone” who said it would provide more nutrition
She was drinking more volume
1 pound weight loss in 1 month
24-hr dietary intake
20 oz of goat milk (rice cereal added at 1T per 4 oz)
3 T baby solids

43. Dietary Analysis Actual Needed Calories 425 (85/kg) 650 min Protein
15-18
Cal dist:
For 6-12 mo 20 15
CHO 30
45-55
Fat 50
35-45

44. Formulas vs Goat Milk Nutrient/8 oz NeoSure Goat Milk Elecare Calories
180
140
Protein, g
4.6 (10%)
8 (23%)
5.3 (14%)
CHO, g
18.5 (41%)
11 (31%)
19 (43%)
Fat, g
9.8 (49%)
7 (46%)
8.5 (43%)
Sodium,mg 41
115 81
Iron, mg
2.2
3.2
Vitamin C,mg 18 16
Folate, μg 31
80 * 53
Vitamin D, IU 86
100 * 77
Osmolality
224
339
330
*Added

45. Choose the appropriate formula:
Infant with galactosemia
Isomil, Prosobee, Pregestimil, Neocate, Elecare
Infant with multiple food allergies
Hydrolysate then Neocate, Elecare
Healthy term infant
Enfamil or Similac
Infant with decreased pancreatic lipase and bile salts
Portagen
Infant with  renal fx and  electrolytes
Similac PM 60/40

46. The End!