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Infant Formulas:Choices and Indications

WIC Formulas, Growth and FeedingOctober 14, 2011

Jan Cox, MS RD CSP

ObjectivesObjectives Identify compositional differences of contract formulas

Identify indications for use of specialty formulas

Discuss methods to handle common infant feeding problems

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Outline Outline

Overview of contract infant formulas Indications for special infant formulas Indications for special infant formulas Case Studies

Benchmark for Infant NutritionBenchmark for Infant NutritionBreastfeeding is the preferred method of infant

feeding to meet optimal growth and feeding to meet optimal growth and development. Benefits are numerous: Protein quality and quantity Low renal solute load Ease of digestion Immunologic agentsg g Decreased incidence/severity of diarrhea Enhances cognitive development Protection against necrotizing enterocolitis

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Barriers to BreastfeedingBarriers to Breastfeeding Young maternal age Lack of prenatal care/educationLack of prenatal care/education Lack of professional knowledge/support Lack of support in the workplace Formula advertising and availability

Only 59% of mothers in the United States Only 59% of mothers in the United States breast feed at hospital discharge.

Only 22% are breast feeding at 6 months.

Breastfeeding in MichiganBreastfeeding in Michigan Ever breastfed 69.1% Breastfeeding at 6 months 35.5%Breastfeeding at 6 months 35.5% Breastfeeding at 12 months 19.8% Exclusive breast for 3 months 31.5% Exclusive breast for 6 months 12.1%

. . . which translates to . . . No breast milk ever 30.9% Some formula at 3 months 68.5% Some formula at 6 months 87.9%

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So, in our quest for a substitute So, in our quest for a substitute breast (milk), what are the breast (milk), what are the

options? options?

Infant Formula ClassificationsInfant Formula Classifications

Standard Infant Formulas

Cow’s milk based

Specialty Infant Formulas

Hydrolyzed protein Cow s milk based◦ Newborn

◦ Infant

◦ Partially hydrolyzed

◦ Rice starch

Soy protein based

Hydrolyzed protein

Free Amino Acid

Lactose-free

Human milk fortifier

Preterm infant

Preterm discharge Preterm discharge

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Cow’s Milk Based Cow’s Milk Based –– NewbornNewborn Indication: Infants 0-3 months 400 IU vitamin D per 27 oz◦ sufficient at 1.5 months (≈ 50th %ile)

◦ standard formulas are sufficient at 2.5 months (≈ 50th %ile)

80:20 whey casein ratio◦ Ratio similar to transitional milk

◦ β-Lactoglobulin not α-Lactalbumin

Not the same as breast milk

Advantage over standard formula???

Cow’s Milk Based Cow’s Milk Based -- InfantInfant Indication: Infants 0-12 months 400 IU vitamin D per 32 oz 60:40 whey casein ratio◦ Ratio similar to mature breast milk

◦ β-Lactoglobulin not α-Lactalbumin

Prebiotics for normal gut flora◦ GOS – galactooligosaccharidesg g

◦ Polydextrose

DHA/ARA fatty acids◦ Worldwide average levels

◦ Supports mental, visual, and immune development

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Cow’s Milk Cow’s Milk –– Partially HydrolyzedPartially Hydrolyzed Indication: fussiness and gas 60:40 whey casein ratio Partially hydrolyzed protein ◦ 60:40 whey casein ratio

◦ Do not use for milk allergy

◦ Uses soy based enzymes

◦ No claims for allergy prevention

◦ Advertised as “easy to digest”

Carbohydrate—no prebiotics◦ Corn syrup solids

◦ Lactose (20%)

DHA/ARA fatty acids

Cow’s Milk Based Cow’s Milk Based -- Rice starchRice starch Indication: Uncomplicated

GER/regurgitation with appropriate positioning and feeding frequency; may be used as “thickened” liquidused as thickened liquid

20:80 whey: casein ratio Carbohydrate◦ Rice starch◦ Lactose (59%)◦ Maltodextrin

Viscosity 10 times routine formula◦ Flows well through standard nipples◦ May be useful for some infants with suck/swallow

dysfunction

Do not concentrate to more than 24 Cal/oz

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Soy Protein BasedSoy Protein Based Indications: galactosemia, lactose intolerance,

or vegan diet

Lactose free Lactose free No proven benefit:◦ Colic

◦ Allergy prevention in high risk family

Do not use for preterm infant (< 1.8 kg or 4 pounds birth weight)( g p g )

Use with caution in cow’s milk protein allergy: o IgE mediated: if + milk, 10-14% + soy

o Non-IgE mediated: if + milk, 30-60% + soy

Allergy/Intolerance: IgE MediatedAllergy/Intolerance: IgE Mediated

Occur immediately with 1-2 hours Cutaneous – urticaria/angioedema: hives Cutaneous – urticaria/angioedema: hives Gastrointestinal – oral itching/abdominal

pain/vomiting diarrhea Respiratory – wheeze, laryngeal edema,

rhinocongitivitis Anaphylaxis (milk = 8-15% of food related

fatal or near fatal reactions; soy < 1%) If + milk, then 10-14% + soy

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Allergy/Intolerance: MixedAllergy/Intolerance: Mixed

Atopic dermatitis◦ 40% may be food related◦ 40% may be food related◦ Milk + eggs + soy + wheat = 90% allergenic

foods

Gastrointestinal◦ Eosinophilic esophagitis—feeding problems,

vomiting, abdominal pain, dysphagia, GER◦ Eosinophilic gastroenteritis—abdominal pain,

vomiting, diarrhea, weight loss

Allergy/Intolerance Allergy/Intolerance –– NonNon--IgEIgE Food protein induced enterocolitis◦ Profuse vomiting and diarrhea 2-3 hours

◦ Dehydration/lethargy

◦ Occult blood loss

◦ Fecal smears: leukocytes and eosinophils

◦ Failure to thrive/ hypoalbuminemia

◦ If + milk, then 45% + soy (30-64%)

If + th 56% + ilk◦ If + soy, then 56% + milk

GER +/- not sole symptom Colic +/- not sole symptom Pulmonary (rare) – cough, wheeze, dyspnea,

recurrent otitis media, nasal congestion, anorexia

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Soy Soy Protein BasedProtein Based

AAP Position Paper◦ Limited indications for use of soy formulaLimited indications for use of soy formula◦ Market Share of 25% of infant formula

Use in Michigan WIC Program◦ 19% of all infants ◦ 0.30% of infants with indicated primary risk

codescodes◦ 17.5% of infants with potential of

contraindicated primary growth risk codes

Extensively Hydrolyzed ProteinExtensively Hydrolyzed Protein Indications: allergy or sensitivity to cow’s

milk and soy proteins

PregestimilPregestimil

◦ Corn syrup solids, dextrose, corn starch

◦ 55% MCT, 45% LCT

Nutramigen

◦ Enflora LGG in powdered product

◦ Corn syrup solids, corn starchy p

◦ 100% LCT

Alimentum –

◦ 70% sucrose, 30% tapioca starch

◦ corn starch in powdered product

◦ 33% MCT, 67% LCT

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Extensively Hydrolyzed ProteinExtensively Hydrolyzed ProteinOther indications:

Pregestimil

• Intractable diarrhea

• Severe food allergies

• Fat intolerance – malabsorption

• Severe protein calorie-malnutrition

Nutramigen

• Allergy to intact cow’s milk and soy proteins

• Severe diarrhea due to food allergy/intolerancegy

• Galactosemia

Alimentum

• Severe food allergies

• Sensitivity to intact protein/protein maldigestion

• Fat malabsorption

Extensively Hydrolyzed ProteinExtensively Hydrolyzed Protein

Use in colic Manufacturers market for use in colic Manufacturers market for use in colic

with relief in 24-48 hours. “Colic” not proven to be protein

sensitivity If changed for this reason by health care

provider re evaluate and retrial on provider, re-evaluate and retrial on contract formula around 4-6 months of age.

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Extensively Hydrolyzed Extensively Hydrolyzed Protein Protein Cost/monthCost/month

Similac Powder $111.69

Isomil Powder $114.30

Enfamil Powder $102.00

Good Start Powder $91.50

Nutramigen LIPIL Powder $184.48

Alimentum Advance Powder $187.12

Pregestimil LIPIL Powder $219.60

Extensively Hydrolyzed ProteinExtensively Hydrolyzed ProteinUse within the Michigan WIC Program 2.7% of infants on Pregestimil LIPIL, Nutramigen

LIPIL Ali t Ad LIPIL or Alimentum Advance 23% with primary growth risk codes (varies

based on clinic – high issuance clinics have lower %)

12% with primary medical risk codes (varies based on clinic – high issuance clinics have glower %)

Majority of risk codes not medically based 70% of issuance is early infancy; if changed back

to contract formula from 6-12 months, would save 1.2 million dollars!

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Free Amino Acid FormulasFree Amino Acid Formulas Products◦ Elecare Infant (Abbott)◦ Nutramigen AA (Mead Johnson)◦ Neocate (Nutricia)

Indications:◦ Multiple food allergies◦ Severe food allergies◦ Eosinophilic gastrointestinal disorders◦ Eosinophilic gastrointestinal disorders◦ Protein maldigestion◦ Malabsorption (Elecare, Neocate)◦ Short bowel syndrome (Elecare, Neocate)

Free Amino Acid FormulasFree Amino Acid Formulas Similarities:◦ Protein = free amino acids ◦ Powdered product only

◦ Protein: 1 3 1 5 times standard formulas◦ Protein: 1.3-1.5 times standard formulas◦ Vitamins: Similar to standard formulas

Differences:◦ Fat Elecare Infant: 67% LCT; 33% MCT Nutramigen AA: 100% LCT Neocate: 85% LCT; 15% MCTNeocate: 85% LCT; 15% MCT

◦ Minerals Elecare Infant: 1.3-2 x standard formula Nutramigen AA: 1.2 x standard formula (Ca, P,

Mg) Neocate: 1.3-2 x standard formula

Scoop size: Neocate 1 scoop/1 oz water

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Amino Acid Based FormulasAmino Acid Based Formulas

Use in Michigan WIC ◦ 0 07% of infants in state on Neocate◦ 0.07% of infants in state on Neocate◦ 31% with birth weight <2500 gms as primary

risk code◦ 15% with GI disorder or lactose intolerance

as primary risk code

Breast feeding and allergyBreast feeding and allergy

Breastfeed exclusively for at least 4 months if infant is at high risk for atopic months if infant is at high risk for atopic disease

Elimination diets in pregnancy and lactation are not recommended to prevent atopic disease

Insufficient evidence for elimination diets for mothers of children with atopic disease

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Breast feeding and allergyBreast feeding and allergy

Low-allergen maternal diet to reduce signs of colic only in infants younger than signs of colic only in infants younger than 6 weeks of age

If an infant has a confirmed food allergy, the causal food should be eliminated from maternal diet

If a breastfeeding mother is avoiding allergenic foods, refer for dietary counseling to prevent deficiency

So, what’s lactose free?So, what’s lactose free?

Soy formula Extensively hydrolyzed formula Extensively hydrolyzed formula Amino acid based formula Similac Sensitive (cow’s milk based)

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Is lactose free ever needed?Is lactose free ever needed? Indications◦ Primary lactase deficiency (extremely rare in y y ( y

infants)◦ Secondary lactase insufficiency

Notes◦ Changing formula for to avoid lactose also

changes other components◦ Similac Sensitive and soy formulas not

indicated for malabsorption disorders

Human Milk FortifierHuman Milk FortifierIndications: Premature infants, birth weight less

than 2 kg (4 lb 6 oz)—particularly than 2 kg (4 lb 6 oz) particularly infants less than 1250 grams (2 lb 12 oz) at birth

Infants with low serum phosphorus levels or osteopenia

Use as directed (1 packet/25 mL human milk) until infant reaches 3 6 human milk) until infant reaches 3.6 kg (8 lb) or achieves appropriate growth pattern (limit 20 packets/day)

Not for use in term infants

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Human Milk Fortifier CompositionHuman Milk Fortifier Composition

Cow’s milk protein/whey

Corn Syrup Solidsy p

LCT and MCT

Adds 3.25 Cal/packet

4 packets/100 mL = 24 Cal/oz

Additional minerals: calcium, phosphorus, magnesium, zinc, (iron),

di d manganese, copper, sodium and potassium

Additional vitamins A, D, E, K, B1, B2, niacin, B6, B12, folic acid, biotin, and pantothenic acid

Premature Infant FormulaPremature Infant Formula

Indications◦ Infants < 34 wks < 1850 g (4 lbs)◦ Infants < 34 wks, < 1850 g (4 lbs)

◦ Up to 2500 (5½ lbs) - 3600 g (8 lbs)

◦ Up to 500 mL (16.7 oz)/day

◦ Rarely used after discharge Weight less than 1850 g (4 lbs) Osteopenia and less than 3600 g (8 lbs)

Composition◦ Protein: nonfat milk + whey

◦ Carbohydrate: corn syrup solids, lactose

◦ Fat: MCT (40-50%), soy oil, other, DHA/ARA

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Enriched FormulasEnriched Formulas

Indications◦ Infant born < 37 wks < 2000 g (4 lb 6 oz)◦ Infant born < 37 wks, < 2000 g (4 lb 6 oz)

◦ Greatest benefit for infants < 1250 g

Composition◦ 22 kcal/oz per label directions

◦ Higher nutrient level/kcal than standard Proteinote Minerals Vitamins

◦ Protein: non-fat milk and whey

◦ Fat: as for preterm; MCT 20-25%

Enriched FormulasEnriched Formulas

Studies recommend for 9 months corrected age or 12 months chronological ageg g g

Until infant reaches genetic growth potential◦ Note growth delay during hospitalization

◦ Note head circumference percentile rank

◦ Note parental heights

Until length/age AND weight/age are at least 10th%il10th%ile

Monitor weight for length – may increase to 95th %ile before catch-up linear growth begins, but weight for length should not exceed 95th

%ile

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Common Feeding ProblemsCommon Feeding ProblemsAKA NonAKA Non--qualifying Conditionsqualifying Conditions——but but conditions conditions which may require which may require our our attention anyway!attention anyway!

Colic or Gastrointestinal Discomfort Frequent emesis Loose stools

Case StudyCase Study

Jackie is a 2 week old female born at 40 weeks gestation Mom presents to your weeks gestation. Mom presents to your WIC clinic with a description of recurrent, prolonged, unexplained crying episodes and wants to try a different formula before everyone in the house goes crazy!

What do you do?

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ColicColic——What is it?What is it?

In an otherwise healthy, well-fed infant:◦ Recurrent, prolonged, unexplained cryingRecurrent, prolonged, unexplained crying◦ Diminished sooth-ability ◦ Increased restlessness◦ Crying >3 hours/day, > 3 days/wk, > 3 wks◦ 20% of all infants regardless of sex, race,

socioeconomic status, birth order,◦ Begins week 2 to 3 of life◦ Peaks at 6 to 9 weeks◦ Resolves by 12 to 16 weeks

ColicColic——What causes it?What causes it?

“Diagnosis of exclusion” Immaturity of the GI system Immaturity of the GI system Immaturity of the central nervous system Difficult infant temperament Parent-infant interaction problems ◦ Infants cues unclear/difficult to read

P h i f ’ d◦ Parents response may not match infant’s need

Carbohydrate malabsorption from fruit juice Cow’s milk/soy protein allergy or intolerance

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ColicColic——What to do?What to do? Refer to PCP Acknowledge difficulty Feeding related questions/coaching◦ Early hunger cues/satiety cues

◦ Underfeeding/overfeeding

Eliminate apple and pear juice Gentlease—partially hydrolyzed proteinp y y y p Extensively hydrolyzed protein—retry standard

formula at 4-6 months Breast feeding: 2 week trial of milk, egg, wheat,

nut free diet

Case StudyCase Study

Theodore is a 3 month old male with a history of vomiting He vomits within 10 to history of vomiting. He vomits within 10 to 20 minutes after nearly every feeding. His growth is within normal limits, in fact his weight is at a higher percentile ranking than either length or head circumference.

What do you do?

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EmesisEmesis——When is it a problem?When is it a problem?

Normal: ◦ “Gentle sloshing” up and out of mouth◦ 1-3 tablespoons per feeding◦ Growth is within normal limits

Problem:◦ Projectile or forceful vomiting

M th 3 t bl f di◦ More than 3 tablespoons per feeding◦ Growth falters◦ Bile, blood, or coffee ground appearance◦ Recurrent upper respiratory tract infections◦ Concurrent with diarrhea

EmesisEmesis——What causes it?What causes it?

Position of gastroesophageal junction Gastroesophageal reflux Gastroesophageal reflux◦ Up to 67% of infants up to 4 months◦ Resolves by 7 to 10 months

Illness: food borne, gastroenteritis, etc. Allergy: with diarrhea, growth falteringAllergy: with diarrhea, growth faltering Intestinal obstruction◦ Pyloric stenosis◦ Intussusception ◦ Intestinal volvulus

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EmesisEmesis——What to do?What to do? Refer to PCP, especially if growth falters If growth is not affected:g◦ Coach hunger/satiety cues◦ Encourage smaller more frequent feedings◦ Check seal on nipple for air swallowing◦ Burp frequently

A id j tli ft f di◦ Avoid jostling after feedings

Consider a trial of Enfamil AR

Case StudyCase Study

Monica is a 7 month old infant who just finished a course of antibiotics for an ear finished a course of antibiotics for an ear infection after an acute episode of gastroenteritis. She continues to have up to six, loose, sometimes watery stools a day. Mom is exhausted from washing and

i i i hi !sanitizing everything!

What do you do?

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DiarrheaDiarrhea——What is it?What is it?

Stools that are: Frequent in number Frequent in number Large in volme Loose to watery in consistency

DiarrheaDiarrhea——What causes it?What causes it? Carbohydrate malabsorption◦ Watery stools, gassy, cramping◦ Stool pH < 6 (acidic)◦ Dehydration sometimes present

Fat malabsorption◦ Large, bulky, oily, foul smelling stools◦ Pale white or grey colored stools◦ Pale, white, or grey colored stools◦ Usually poor weight gain

Protein allergy—usually accompanied by other symptoms: vomiting, atopic dermatitis, wheezing, bloody stool

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DiarrheaDiarrhea——What to do?What to do? Refer to PCP Carbohydrate:y◦ Gentlease—20% lactose◦ Prosobee—no lactose◦ Retry standard formula after 2 weeks

Fat: medical condition specific Protein allergy:◦ Extensively hydrolyzed protein formula◦ Amino acid based formula◦ Maternal elimination of offending allergen

In SummaryIn Summary Identify compositional differences of contract formulas

Identify indications for use of specialty formulas

Discuss methods to handle common infant feeding problems