Infant Formulas What

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Infant FormulasWhats for What and Whats for
Whom???
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Infant Formula

• Product intended for use by infants that
  simulates human milk or is suitable as a complete
  or partial substitute for human milk

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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

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Examples of Early Infant Feeding Vessels
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Commercial Formula Development

• In 1867, Henri Nestlé created the first
  commercially sold formula.

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• 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

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• 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

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• Good rubber nipples made feeding easier

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• 1911-- Dextri-Maltose introduced by Mead Johnson
• 1915 -- a formula called synthetic milk adapted
  (forerunner of Wyeths SMA) required only the
  addition of water
• 67 kcal/dL
• Non-fat cow milk
• Lactose
• Oleo and vegetable fat

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

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Highlights in Formula History

• 1929--the first soy flour formula was developed
• milkfree, lactosefree
• designed as an alternative to the home prepared
  milkbased formulas of the time
• soy flour caused significant abd discomfort
• 1942--protein hydrolysate formula
• 1959iron-fortified formula appeared
• 1960appreciation of renal solute load
• 1965--soy protein isolate formula

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• 19661st premmie formula designed to meet the
  special nutritional needs of rapidly growing
  lowbirthweight infants.
• 1971--first nutritionally complete protein
  hydrolysate formula containing MCT oil.
• 1990s
• lactose free cow milk-based formulas appeared
• Nucleotides were added to some formulas
• Early 2000s
• DHA and ARA were added to both cow milk and soy
  formulas

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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.

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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

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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.
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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.
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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.
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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.
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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.
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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 Stepolder infants and toddlers
• Specialized
• Modified for specific medical indication
• Metabolic, renal, GI disorders

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Standard Formulas

• Cow milk altered by
• 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 ß-lactoglobulin
• Major casein protein is bovine ?-casein
• Amino acid profile varies
• Taurine and carnitine are added to some

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Whey to Casein Ratio
Whey Casein
Breast milk 70 ?-lactalbumin, lactoferrin, IgA 30 ß-casein
Enfamil 60 40
Similac 18 82
Carnation Good Start 100 0
Soy 0 0
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Standard Formula Features

• Breast milk
• 20cal/oz
• Human milk fat
• Lactose
• wheycasein 7030
• 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
• 6040, 1882
• ? 15 g/L
• Iron 12mg/L
• Vitamin D 405 IU/L
• 265-300 mOsm/kg H20
• DHA and AA added
• Formulas still made without

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Low Iron Formula
PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123
AMERICAN ACADEMY OF PEDIATRICSIron
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.
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Soy Formulas

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

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Soy Formulas

• Breast milk
• 20cal/oz
• Human milk fat
• Lactose
• wheycasein 7030
• 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/Lsoy isolate and L-MET
• Iron 12mg/L
• Vitamin D 405 IU/L
• 200 mOsm/kg H20
• DHA and AA added

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Protein Hydrolysates

• Hydrolyzed casein or whey protein
• Various fat blends
• All are lactose free

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Protein Hydrolysates

• Pregestimil
• 20cal/oz
• 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
• 70whey 30casein
• 9 g/L
• Iron 0.3mg/L
• Vit D 21 IU/L
• 260 mOsm/kg H20
• Contains DHA and AA

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Other Hydrolysates

• Alimentum Advance
• 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

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• 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
• Wheycasein ratio of 6040
• 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

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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

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Elemental

• Breast milk
• 20cal/oz
• Human milk fat
• Lactose
• 70whey 30casein
• 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

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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

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Premature Infants

• Hospital discharge
• NeoSure
• EnfaCare
• 22 kcal/oz
• ? Pro, calcium, phosphorus, MCT (20)
• Cow milk based
• Improved growth
• Wheeler, RE. Journal of Perinatology,
  16111-116, 1996.

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Specialized

• Portagen
• 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

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Specialized, cont

• Similac PM 60/40
• 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

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Toddler Formulas

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

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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

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Case

• 10.5 mo old female with hx of poor growth
• 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
• Medssynthroid, zantac, Poly-vi-sol, flovent,
  calcium gluconate

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• Weight--5 kg
• Length-- 61.6 cm
• IBW--6.5 kg
• 77 of IBW

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• Dietary data
• 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

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Dietary Analysis
Actual Needed
Calories 425 (85/kg) 650 min
Protein 22 (4.4/kg) 15-18
Cal dist For 6-12 mo
Protein 20 15
CHO 30 45-55
Fat 50 35-45
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Formulas vs Goat Milk
Nutrient/8 oz NeoSure Goat Milk Elecare
Calories 180 140 180
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 0 3.2
Vitamin C,mg 18 0 16
Folate, µg 31 80 53
Vitamin D, IU 86 100 77
Osmolality 224 339 330
Added
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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

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The End!