Infant FormulasInfant FormulasWhat’s for What and What’s for What’s for What and What’s for

Whom???Whom???

Infant FormulaInfant Formula

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

Historical PerspectiveHistorical Perspective

Early attempts at artificial feeding of infants Early attempts at artificial feeding of infants employed the milk of other mammalsemployed the milk of other mammals– Infant survival during the 1Infant survival during the 1stst few weeks of life few weeks of life

approached 0%approached 0%

Wet nurses were employed but their Wet nurses were employed but their availability declined with the onset of the availability declined with the onset of the Industrial Revolution Industrial Revolution

Examples of Early Examples of Early Infant Feeding Infant Feeding

VesselsVessels

Pewter

Ceramic

Commercial Formula Commercial Formula DevelopmentDevelopment

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

Banana feeder

At the end of the 19At the end of the 19thth century the gross century the gross composition of human milk was composition of human milk was determined. determined. Recognition of low concentration of protein Recognition of low concentration of protein in BM lead to the use of diluted cow milkin BM lead to the use of diluted cow milk– Less mortality among infantsLess mortality among infants– But poor growthBut poor growth

To increase caloric density of diluted cow To increase caloric density of diluted cow milk, sugar or cereals were addedmilk, sugar or cereals were added– Infants lived and grewInfants lived and grew– Pediatrics became a medical specialtyPediatrics became a medical specialty– Mortality still remained high Mortality still remained high

Early 20Early 20thth century century – Electric refrigeration and pasteurizationElectric refrigeration and pasteurization

Significant decrease in mortalitySignificant decrease in mortality

Increased popularity of formula feedingIncreased popularity of formula feeding

– Improved sanitation and milk handlingImproved sanitation and milk handling

– Modifications in cow protein improved Modifications in cow protein improved digestibilitydigestibility

– Direct advertising to physicians Direct advertising to physicians influenced use of formulasinfluenced use of formulas

– Good rubber nipples made feeding Good rubber nipples made feeding easiereasier

1911-- Dextri-Maltose introduced by 1911-- Dextri-Maltose introduced by Mead JohnsonMead Johnson

1915 -- a formula called 1915 -- a formula called synthetic synthetic milk adapted milk adapted (forerunner of Wyeth’s (forerunner of Wyeth’s SMA) required only the addition of SMA) required only the addition of waterwater– 67 kcal/dL67 kcal/dL

– Non-fat cow milkNon-fat cow milk

– LactoseLactose

– Oleo and vegetable fatOleo and vegetable fat

The importance of vitamins was The importance of vitamins was recognizedrecognized– Infant formulas became suitable vehiclesInfant formulas became suitable vehicles– Previously common vitamin-deficiency Previously common vitamin-deficiency

diseases such as scurvy and rickets became diseases such as scurvy and rickets became less prevalentless prevalent

Highlights in Formula HistoryHighlights in Formula History

1929--the first soy flour formula was 1929--the first soy flour formula was developeddeveloped– milk–free, lactose–free milk–free, lactose–free – designed as an alternative to the home designed as an alternative to the home

prepared milk–based formulas of the timeprepared milk–based formulas of the time– soy flour caused significant abd discomfort soy flour caused significant abd discomfort

1942--protein hydrolysate formula1942--protein hydrolysate formula1959—iron-fortified formula appeared 1959—iron-fortified formula appeared 1960—appreciation of renal solute load 1960—appreciation of renal solute load 1965--soy protein isolate formula1965--soy protein isolate formula

1966—11966—1stst premmie formula designed to premmie formula designed to meet the special nutritional needs of meet the special nutritional needs of rapidly growing low–birth–weight infants. rapidly growing low–birth–weight infants. 1971--first nutritionally complete protein 1971--first nutritionally complete protein hydrolysate formula containing MCT oil. hydrolysate formula containing MCT oil. 1990’s1990’s– lactose free cow milk-based formulas lactose free cow milk-based formulas

appearedappeared– Nucleotides were added to some formulasNucleotides were added to some formulas

Early 2000’sEarly 2000’s– DHA and ARA were added to both cow milk DHA and ARA were added to both cow milk

and soy formulasand soy formulas

Infant Formula Act Passed by Infant Formula Act Passed by Congress in 1980Congress in 1980

Following reports in 1979 that over 100 infants Following reports in 1979 that over 100 infants became seriously ill because of the lack of became seriously ill because of the lack of chloride in two soy-based formulaschloride in two soy-based formulas

The new law authorized the FDA to adjust The new law authorized the FDA to adjust nutritional standards for infant foods to conform nutritional standards for infant foods to conform with the best available scientific knowledge. with the best available scientific knowledge.

Manufacturers are required to test their Manufacturers are required to test their products periodically and report to the FDA products periodically and report to the FDA when they do not meet the official specs.when they do not meet the official specs.

Furthermore….Formula Furthermore….Formula Manufacturers are required toManufacturers are required to

Verify composition before a new product Verify composition before a new product goes to market goes to market – specifying that it meets minimum (29 specifying that it meets minimum (29

nutrients) and does not exceed maximum (9 nutrients) and does not exceed maximum (9 nutrients) requirementsnutrients) requirements

Meet “good manufacturing practices”Meet “good manufacturing practices”Maintain records for annual inspectionMaintain records for annual inspectionThe FDA has the authority to recall The FDA has the authority to recall products that are adulterated or products that are adulterated or misbrandedmisbranded

The types of formula feedingThe 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.

Forms of formula: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.

Types of formulaTypes 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 protein3-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.

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.

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.

Categories of Infant formulasCategories of Infant formulasStandardStandard– Similac, Enfamil, Carnation, Store brands Similac, Enfamil, Carnation, Store brands

SoySoy– Isomil, Prosobee, Alsoy, Isomil, Prosobee, Alsoy,

Protein hydrolysatesProtein hydrolysates– Pregestimil, Nutramigen, AlimentumPregestimil, Nutramigen, Alimentum

ElementalElemental– Neocate, ElecareNeocate, Elecare

PrematurePremature– Enfacare, NeoSureEnfacare, NeoSure

““Next Step”—older infants and toddlersNext Step”—older infants and toddlersSpecializedSpecialized– Modified for specific medical indicationModified for specific medical indication

Metabolic, renal, GI disordersMetabolic, renal, GI disorders

Standard FormulasStandard FormulasCow milk altered by Cow milk altered by – Removing the butter fatRemoving the butter fat– Adding vegetable oils and carbohydrateAdding vegetable oils and carbohydrate– Decreasing the proteinDecreasing the protein

34 g/L to 34 g/L to 15 g/L15 g/L

– Adding vitamins, minerals, and other nutrients such Adding vitamins, minerals, and other nutrients such as amino acids, fatty acids, nucleotidesas amino acids, fatty acids, nucleotides

Whey to casein ratio variesWhey to casein ratio varies– Major whey protein is Major whey protein is ββ-lactoglobulin-lactoglobulin– Major casein protein is bovine Major casein protein is bovine -casein-casein– Amino acid profile variesAmino acid profile varies– Taurine and carnitine are added to someTaurine and carnitine are added to some

Whey to Casein RatioWhey to Casein Ratio% Whey% Whey % Casein% Casein

Breast milkBreast milk 70 70 -lactalbumin, -lactalbumin, lactoferrin, IgAlactoferrin, IgA

30 30

ββ-casein-casein

EnfamilEnfamil 6060 4040

SimilacSimilac 1818 8282

Carnation Carnation

Good StartGood Start

100100 00

SoySoy 00 00

Standard Formula FeaturesStandard Formula Features

Breast milkBreast milk– 20cal/oz20cal/oz– Human milk fatHuman milk fat– LactoseLactose– whey:casein 70:30whey:casein 70:30

9 g/L9 g/L– Iron 0.3mg/LIron 0.3mg/L– Vitamin D 21 IU/LVitamin D 21 IU/L

– 260 mOsm/kg H260 mOsm/kg H2200

– Contains DHA and AAContains DHA and AA

Infant formulaInfant formula– 20cal/oz20cal/oz– Soy, coconut, sunflower, palm Soy, coconut, sunflower, palm – LactoseLactose– 60:40, 18:82 60:40, 18:82

15 g/L15 g/L– Iron 12mg/LIron 12mg/L– Vitamin D 405 IU/LVitamin D 405 IU/L

– 265-300 mOsm/kg H265-300 mOsm/kg H2200

– DHA and AA added DHA and AA added Formulas still made withoutFormulas still made without

Low Iron FormulaLow Iron Formula

“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.”

PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123 AMERICAN ACADEMY OF PEDIATRICS:Iron Fortification of Infant Formulas Position Statement

Soy FormulasSoy FormulasIndications for useIndications for use– Milk protein intolerance (IGE mediated)Milk protein intolerance (IGE mediated)– Lactose intolerance (rare)Lactose intolerance (rare)– GalactosemiaGalactosemia– Vegetarian dietVegetarian diet

Not appropriate for Not appropriate for – preterm infants < 1800 grams d/t risk of preterm infants < 1800 grams d/t risk of

osteopenia and growth concernsosteopenia and growth concerns– Hereditary fructose intolerance (contains Hereditary fructose intolerance (contains

sucrose)sucrose)

Soy FormulasSoy Formulas

Breast milkBreast milk– 20cal/oz20cal/oz– Human milk fatHuman milk fat– LactoseLactose– whey:casein 70:30whey:casein 70:30

9 g/L9 g/L– Iron 0.3mg/LIron 0.3mg/L– Vitamin D 21IU/LVitamin D 21IU/L– 260 mOsm/kg H260 mOsm/kg H2200– Contains DHA and Contains DHA and

AAAA

formulaformula– 20cal/oz20cal/oz– palm olein, palm olein,

soy,coconut,sunflowersoy,coconut,sunflower– Corn syrup/sucroseCorn syrup/sucrose– Protein, 17 g/LProtein, 17 g/L

soy isolate and L-METsoy isolate and L-MET– Iron 12mg/LIron 12mg/L– Vitamin D 405 IU/LVitamin D 405 IU/L

– 200 mOsm/kg H200 mOsm/kg H2200

– DHA and AA addedDHA and AA added

Protein HydrolysatesProtein Hydrolysates

Hydrolyzed casein or whey proteinHydrolyzed casein or whey protein

Various fat blendsVarious fat blends

All are lactose freeAll are lactose free

Protein HydrolysatesProtein Hydrolysates

Breast milkBreast milk– 20cal/oz20cal/oz– Human milk fatHuman milk fat– LactoseLactose– 70%whey 30%casein70%whey 30%casein

9 g/L9 g/L– Iron 0.3mg/LIron 0.3mg/L– Vit D 21 IU/LVit D 21 IU/L– 260 mOsm/kg H260 mOsm/kg H2200– Contains DHA and AAContains DHA and AA

PregestimilPregestimil– 20cal/oz20cal/oz– MCT (55%), safflower, soyMCT (55%), safflower, soy– corn syrup solids, corn starchcorn syrup solids, corn starch– Casein Hydrolysate-Casein Hydrolysate-

nonantigenic peptidesnonantigenic peptides

19 g/L19 g/L– Iron 12mg/LIron 12mg/L– Vitamin D 405 IU/LVitamin D 405 IU/L

– 330 mOms/kg H330 mOms/kg H2200

– Does not have DHA and AADoes not have DHA and AA

Other HydrolysatesOther Hydrolysates

Alimentum AdvanceAlimentum Advance– For infants and children with severe food allergies, For infants and children with severe food allergies,

sensitivity to intact protein (including colic symptoms sensitivity to intact protein (including colic symptoms due to protein sensitivity), protein maldigestion or fat due to protein sensitivity), protein maldigestion or fat malabsorption malabsorption

– Hydrolyzed casein + free amino acidsHydrolyzed casein + free amino acids– 33% of fat is MCT33% of fat is MCT– 370 mOms/kg H370 mOms/kg H2200– Contains DHA and ARAContains DHA and ARA– Lactose free (contains sucrose)Lactose free (contains sucrose)

Nutramigen LIPILNutramigen LIPIL– hypoallergenic hypoallergenic – for infants who are sensitive to intact protein for infants who are sensitive to intact protein

in milk and soy-based formulasin milk and soy-based formulas– 270 mOms/kg H270 mOms/kg H2200– Lactose and sucrose free Lactose and sucrose free

Enfamil Gentlease LIPILEnfamil Gentlease LIPIL– Launched in July 05Launched in July 05– ““is a nutritionally balanced, milk-based is a nutritionally balanced, milk-based

infant formula designed as a first switch infant formula designed as a first switch formula for babies who have fussiness or gas.” formula for babies who have fussiness or gas.”

– Partially broken down proteins Partially broken down proteins 6-9% hydrolyzed6-9% hydrolyzed

– Reduced lactoseReduced lactose1/4 of typical1/4 of typical

– Whey:casein ratio of 60:40Whey:casein ratio of 60:40– Contains DHA and ARA, “nutrients also found in Contains DHA and ARA, “nutrients also found in

breast milk that promote brain and eye development.”breast milk that promote brain and eye development.”– No studies to document efficacy in the intended No studies to document efficacy in the intended

populationpopulation

Elemental FormulasElemental Formulas

Indications: For infants and children who Indications: For infants and children who need an amino acid-based medical food or need an amino acid-based medical food or who cannot tolerate intact protein who cannot tolerate intact protein – protein maldigestion or malabsorptionprotein maldigestion or malabsorption

Short bowel syndromeShort bowel syndrome

– severe or multiple food allergiessevere or multiple food allergies– GI tract impairmentGI tract impairment

eosinophilic esophagitis or gastroenteritiseosinophilic esophagitis or gastroenteritis

– Lactose, sucrose, fructose, and galactose-Lactose, sucrose, fructose, and galactose-freefree

Galactosemia and hereditary fructose intoleranceGalactosemia and hereditary fructose intolerance

ElementalElemental

Breast milkBreast milk– 20cal/oz20cal/oz– Human milk fatHuman milk fat– LactoseLactose– 70%whey 30%casein70%whey 30%casein

9 g/L9 g/L– Iron 0.3mg/LIron 0.3mg/L– Vit D 21 IU/L Vit D 21 IU/L

– 260 mOsm/kg H260 mOsm/kg H2200

– Contains DHA and AAContains DHA and AA

Neocate/ElecareNeocate/Elecare– 20cal/oz20cal/oz– MCT, safflower, soyMCT, safflower, soy– Corn syrup solidsCorn syrup solids– 100% free amino acids, 100% free amino acids,

21 g/L21 g/L– Iron 12mg/LIron 12mg/L– Vitamin D 500 IU/LVitamin D 500 IU/L

– 335 mOsm/kg H335 mOsm/kg H2200

– Do not contain DHA and Do not contain DHA and AAAA

Premature FormulasPremature FormulasNICUNICU– Similac Special Care Similac Special Care

Enfamil Premature LipilEnfamil Premature Lipil20 and 24 kcal/oz20 and 24 kcal/ozAvailable only for inpatientsAvailable only for inpatientsCow milk basedCow milk based40% of fat is MCT40% of fat is MCT

Products are not appropriate for Products are not appropriate for larger babies (2.5-3 kg) because of larger babies (2.5-3 kg) because of higher amounts of vitamins (esp A higher amounts of vitamins (esp A and D) and mineralsand D) and minerals

Premature InfantsPremature Infants

Hospital dischargeHospital discharge– NeoSureNeoSure– EnfaCareEnfaCare

22 kcal/oz 22 kcal/oz

Pro, calcium, Pro, calcium, phosphorus, MCT (20%)phosphorus, MCT (20%)

Cow milk basedCow milk based

Improved growthImproved growth– Wheeler, RE. Journal of Perinatology, Wheeler, RE. Journal of Perinatology,

16:111-116, 1996.16:111-116, 1996.

SpecializedSpecializedPortagen Portagen – 86% MCT oil fat malabsorption, intestinal lymphatic 86% MCT oil fat malabsorption, intestinal lymphatic

obstruction, or chylothoraxobstruction, or chylothorax– 2002 recall after the death of a premature infant from 2002 recall after the death of a premature infant from

Enterbacter sakazakii contaminated formula. Enterbacter sakazakii contaminated formula. – Manufacturer no longer recommends for infantsManufacturer no longer recommends for infants

RCF Ross Carbohydrate FreeRCF Ross Carbohydrate Free– Infants with CHO intoleranceInfants with CHO intolerance– Must add CHOMust add CHO– Modified for the ketogenic dietModified for the ketogenic diet

Specialized, cont:Specialized, cont:

Similac PM 60/40Similac PM 60/40– For infants with hypocalcemia For infants with hypocalcemia

due to hyperphosphatemia due to hyperphosphatemia or impaired renal function. or impaired renal function.

Metabolic FormulasMetabolic Formulas– PKU, MSUD, tyrosinemia, PKU, MSUD, tyrosinemia,

homocystinuria, glutaric aciduria, homocystinuria, glutaric aciduria, PPA/MMA, urea cyclePPA/MMA, urea cycle

– Ross, Mead Johnson, Ross, Mead Johnson, Scientific Hospital SuppliesScientific Hospital Supplies

ToddlerToddler FormulasFormulasMilk and soy based Milk and soy based productsproducts

for infants and toddlersfor infants and toddlers– 9-24 months9-24 months– who are eating solid foodswho are eating solid foods

Contain DHA and ARAContain DHA and ARA

Has > twice the calcium Has > twice the calcium of regular infant formulas of regular infant formulas (300 mg vs 125 mg) (300 mg vs 125 mg)

Alternatives to Infant FormulasAlternatives to Infant Formulas

Evaporated Milk FormulaEvaporated Milk Formula– AAP does not support its useAAP does not support its use

Poorly digested fatPoorly digested fat

Low iron and vitamin CLow iron and vitamin C

Excessive sodium, protein, PO4Excessive sodium, protein, PO4

– Preferable to unmodified cow milkPreferable to unmodified cow milk– RecipeRecipe

13 oz can13 oz can

19.5 oz water19.5 oz water

3 Tablespoons sugar or corn syrup3 Tablespoons sugar or corn syrup

– Requires supplementation with vitamins A, D, Requires supplementation with vitamins A, D, calcium, and ironcalcium, and iron

CaseCase10.5 mo old female with hx 10.5 mo old female with hx of poor growthof poor growth– 26.5 weeks gestation26.5 weeks gestation– 3 mo NICU course 3 mo NICU course

complicated by poor feeding, complicated by poor feeding, BPD, hernia repair, seizuresBPD, hernia repair, seizures

Discharged on Elecare and ODischarged on Elecare and O22

7.5 mo corrected age7.5 mo corrected age– Meds—synthroid, zantac, Meds—synthroid, zantac,

Poly-vi-sol, flovent, calcium Poly-vi-sol, flovent, calcium gluconategluconate

Weight--5 kg Weight--5 kg

Length-- 61.6 cmLength-- 61.6 cm

IBW--6.5 kgIBW--6.5 kg

77% of IBW77% of IBW

Dietary dataDietary data– Family had switched to goat Family had switched to goat

milk 1 mo prior on the advice of milk 1 mo prior on the advice of “someone” who said it would “someone” who said it would provide more nutritionprovide more nutrition

– She was drinking more volumeShe was drinking more volume– 1 pound weight 1 pound weight lossloss in 1 month in 1 month

24-hr dietary intake24-hr dietary intake– 20 oz of goat milk 20 oz of goat milk

(rice cereal added at (rice cereal added at 1T per 4 oz)1T per 4 oz)

– 3 T baby solids3 T baby solids

Dietary AnalysisDietary AnalysisActualActual NeededNeeded

CaloriesCalories 425 (85/kg)425 (85/kg) 650 min650 min

ProteinProtein 22 (4.4/kg)22 (4.4/kg) 15-1815-18

Cal dist:Cal dist: For 6-12 moFor 6-12 mo

ProteinProtein 2020 1515

CHOCHO 3030 45-5545-55

FatFat 5050 35-4535-45

Formulas vs Goat MilkFormulas vs Goat Milk

Nutrient/8 ozNutrient/8 oz NeoSureNeoSure Goat MilkGoat Milk ElecareElecare

CaloriesCalories 180180 140140 180180

Protein, gProtein, g 4.6 (10%)4.6 (10%) 8 (23%)8 (23%) 5.3 (14%)5.3 (14%)

CHO, gCHO, g 18.5 (41%) 18.5 (41%) 11 (31%)11 (31%) 19 (43%)19 (43%)

Fat, gFat, g 9.8 (49%)9.8 (49%) 7 (46%)7 (46%) 8.5 (43%)8.5 (43%)

Sodium,mgSodium,mg 4141 115115 8181

Iron, mgIron, mg 2.22.2 00 3.23.2

Vitamin C,mgVitamin C,mg 1818 00 1616

Folate, Folate, μμgg 3131 80 *80 * 5353

Vitamin D, IUVitamin D, IU 8686 100 *100 * 7777

OsmolalityOsmolality 224224 339339 330330*Added

Choose the appropriate formulaChoose the appropriate formula::

Infant with galactosemiaInfant with galactosemia– Isomil, Prosobee, Pregestimil, Neocate, ElecareIsomil, Prosobee, Pregestimil, Neocate, Elecare

Infant with multiple food allergiesInfant with multiple food allergies– Hydrolysate then Neocate, ElecareHydrolysate then Neocate, Elecare

Healthy term infantHealthy term infant– Enfamil or SimilacEnfamil or Similac

Infant with decreased pancreatic lipase and Infant with decreased pancreatic lipase and bile saltsbile salts– PortagenPortagen

Infant with Infant with renal fx and renal fx and electrolytes electrolytes– Similac PM 60/40Similac PM 60/40

The End!