Idaho Medical Home Portal

Formula Use

While breast milk is recommended for infants in most situations, formula is often used in infancy when breast milk is not available or contraindicated. Formula can also be given to older children who are unable to obtain adequate nutrition through conventional means. Formula comes in 3 different forms:

Ready to feed (does not need to be prepared with water)
Powdered (must be mixed with water, but is the least expensive form)
Concentrated liquid

Delivery of formula can involve use of a cup, spoon, supplemental nursing system, bottle, or feeding tube (see Feeding Tubes and Gastrostomies). The nutritional content of formula is regulated by the U.S. Food & Drug Administration based on recommendations by the Committee on Nutrition (AAP). Nutritional requirements, digestive concerns, metabolic demands, and age of the child drive the selection of one formula over another. Background information on the many types of formulas available and detailed information about the different components of formula and the rationale for their use are presented below.

The links, below, lead to charts that list the major brands of formula and key differences among their ingredients.

Pearls and Alerts

When to stop preterm formula: Preterm infant formula and human milk fortifiers are designed to meet the increased vitamin and mineral needs of the preterm infant consuming smaller volumes than the term infant consumes. Continuation of the preterm infant formula and human milk fortifiers in infants who weigh more than 2.5-3.0 kg will result in increased intakes of several vitamins, including vitamins A and D. Case reports of hypervitaminosis D suggest that these products should be discontinued when the infant is exceeding the recommend intakes for fat-soluble vitamins.
Formula feeding contraindications: These include vomiting or spit-up associated with inadequate weight gain, colic, constipation or diarrhea, blood or mucus in stool, severe or difficult to treat eczema, hives, and anaphylaxis.
Aluminum toxicity: Preterm infants and infants that were intrauterine growth restricted who use soy formula may be at risk of aluminum toxicity. [Fanni: 2014]

Formula Components

Six basic components compose formula - protein, fat, carbohydrate, vitamins, minerals, and other nutrients. What makes one brand of formula different from the next is the specific carbohydrates, fats, and proteins it uses, as well as any additional ingredients. These differences and their indicated use are explained below. The Medical Home Portal does not endorse a specific brand or preparation; however, commercially prepared formulas will be mentioned here to provide examples. International recommendations for formula composition can be found at [Koletzko: 2005].

PROTEIN

Cow milk protein. Cow milk proteins include whey and casein. While whey and casein are also in human milk, there are differences between the whey in human milk and the whey in cow milk. Protein content of cow milk based formulas tends to be higher than in human milk and can result in increased amino acid levels (of unclear clinical significance). [Committee: 2013] Infants with documented cow milk, protein-induced enteropathy or enterocolitis frequently are as sensitive to soy protein and should not be given isolated soy protein based formula routinely. They should be provided formula derived from hydrolyzed protein or synthetic amino acid. [Jatinder: 2008]
- Indications for use: Typically, first line replacement for breastmilk
- Examples: Similac Advance, Enfamil LIPIL, many store brand formulas

Soy protein. The protein is a soy isolate supplemented with L-methionine, L-carnitine, and taurine to provide a protein content of 2.45-2.8 g per 100 kcal, or 1.65-1.9 g/dL. Approximately 10-14% of infants with an allergy to cow milk protein will also have allergy to soy protein. [Committee: 2013] This proportion can be up to 60% higher in infants with proctitis or enterocolitis as a result of protein intolerance. Concerns raised in relation to phytoestrogens/isoflavones include their potential negative effects on sexual development and reproduction, neurobehavioral development, immune function, and thyroid function; although studied by numerous investigators in various species, there is no conclusive evidence that dietary soy isoflavones may adversely affect human development, reproduction, or endocrine function. [Jatinder: 2008] Epidemiologic studies have suggested a protective effect of isoflavones against a number of adult chronic diseases, including coronary heart disease and breast, endometrial, and prostate cancers. [Jatinder: 2008]
- Indications for use: Galactosemia, hereditary lactase deficiency, IgE mediated allergy to cow milk, vegetarian, secondary lactose intolerance related to acute gastroenteritis. Soy protein based formulas are not designed or recommended for preterm infants who weigh <1800 g. [Committee: 2013] The routine use of isolated soy protein based formula has no proven value in the prevention or management of infantile colic, or prevention of atopic disease. [Jatinder: 2008]
- Examples: Isomil, ProsoBee, Nestle/Gerber Good Start Soy

Partially hydrolyzed protein. Cow milk proteins (whey and/or casein) are broken into portions, making them somewhat easier to digest. Some formulas add probiotics and/or omega-3 and -6. It should be noted that the FDA concluded there is little evidence to support the relationship between intake of partially hydrolyzed 100% whey protein infant formula (W-PHF) and a reduced risk of atopic dermatitis in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. [Carolyn: 2012] In addition, the FDA requires a warning statement to indicate that partially hydrolyzed infant formulas are not hypoallergenic, and they should not be fed to infants who are allergic to milk or have existing milk allergy symptoms. [Carolyn: 2012]
- Indications for use: Prevention of atopic dermatitis, but not for infants with cow milk protein intolerance
- Examples: Nestle/Gerber (aka Carnation) Good Start products

Extensively hydrolyzed protein. Through a heat and enzymatic process, casein is broken into small portions (peptides and amino acids), which are then generally not recognized by the body as an allergen. Taste and cost can be a limiting factor for use.
- Indications for use: Infants diagnosed with allergy to cow milk protein.
- Example: Gerber extensive HA

Amino acid based protein (aka Elemental). Taste and cost can be a limiting factor for use.
- Indications for use: When extensively hydrolyzed formulas are not tolerated and there is extreme protein hypersensitivity.
- Examples: Enfamil PurAmino, Nutricia Neocate

FAT

Typically, almost half of the calories in cow milk based formulas are from fat that is formulated to provide an appropriate and absorbable blend of essential fatty acids. The fat is usually derived from vegetable oils such as palm olein, soy, coconut, high-oleic sunflower or safflower, plus occasionally animal fats. [Committee: 2013] Many formulas include added long-chain poly-unsaturated ARA and DHA omega fatty acids. The sources of these are single cell organisms.

Medium chain triglycerides. Some formulas contain increased medium chain triglycerides and other features making it more readily digestible.
- Indications for use: For fat malabsorption, such as in short bowel syndrome, cystic fibrosis, and intractable diarrhea
- Example: Pregestimil
Long chain triglycerides (ketogenic). Provides 3-4 grams of fat for every 1 gram of carbohydrate and protein. The kinds of foods that provide fat for the ketogenic diet are butter, heavy whipping cream, mayonnaise, and oils (e.g., canola or olive). See Ketogenic Diet for more information.
- Indications for use: For children whose seizures have not responded to several different seizure medicines: Only for use in close consultation with a neurologist. Usually, dieticians recommend a daily diet that contains 75-100 calories for every kilogram (2.2 pounds) of body weight and 1-2 grams of protein for every kilogram of body weight. [Epilepsy: 2014]
- Examples: Nutricia KetoCal, Solace KetoVolve

CARBOHYDRATE

Lactose is the main carbohydrate in human milk as well as in many formulas. It breaks down to glucose and galactose. Corn maltodextrin is sometimes used as a secondary source of carbohydrate in formula. Complex carbohydrates, also known as starches, are used in some formulas as thickeners to help with gastroesophageal reflux.

Alternatives to lactose. These include sucrose, corn syrups, tapioca starch, maltodextrins, and other modified starches.
- Indications for use: Congenital lactase deficiency, which is rare, and lactose intolerance (not a common infant condition)
- Examples: Enfamil ProSobee, Baby’s Only Organic LactoRelief, Similac Sensitive
Added starch. Typically contains added rice starch
- Indications for use: Gastroesophageal reflux
- Examples: Enfamil A.R., Similac for Spit-Up

ELECTROLYTES, MINERALS, AND VITAMINS

These include major and trace (FDA-regulated) minerals and vitamins.

Iron: Quantities vary in different types of formulas to adjust for absorption. Standard infant formulas contain 10-12 mg/L. Low-iron formulas contain 4-6 mg/L, but are not routinely recommended. Caregivers may be concerned that the iron upsets their infant's stomach or causes constipation, but no scientific evidence demonstrates this effect. [Committee: 2013]
- Indications for use: Neonatal hemochromatosis (rare), impaired renal function
- Example: Similac PM 60/40 Low Iron, Similac Lower Iron, Enfamil Lower Iron
Aluminum: Although the aluminum content of human milk is 4-65 ng/mL, soy protein based formula is 600-1300 ng/mL. [Jatinder: 2008] Because aluminum competes with calcium for absorption, increased amounts of dietary aluminum from isolated soy protein based formula may contribute to the reduced skeletal mineralization (osteopenia) observed in preterm infants and infants with intrauterine growth retardation. [Jatinder: 2008] Term infants with normal renal function do not seem to be at substantial risk of developing aluminum toxicity from soy protein based formulas. [Jatinder: 2008]
Other optionally added nutrients: Includes taurine [Verner: 2007], lutein, choline, carnitine ([Kumar: 2004], nucleotides [Singhal: 2010], Vitamin E, DHA, and other lipids
- Indications for use: To more closely simulate breast milk composition and to provide additional supplementation to preterm or low birth weight infants.
- Example: Many formulas highlight some of these components, including Similac OptiGro, Enfamil Infant, and Honest Co. Organic Premium Infant

OTHER NUTRIENTS

Probiotics: Probiotics are supplements containing organisms that change the microflora of the host. These organisms are typically Lactobacillus, Bifidobacterium, and Streptococcus species. The addition of probiotics to powdered infant formula has not been proven harmful to healthy term infants. However, there is no current evidence of clinical effectiveness and the routine use of these formulas is not recommended.
Prebiotics: Prebiotics are supplements containing a nondigestible ingredient, usually in the form of oligosaccharides, which selectively stimulates the favorable growth or activity of indigenous probiotic bacteria. Human milk contains substantial quantities of prebiotics and is preferred for infants up to 6 months of age. The addition of oligosaccharides as prebiotics to infant formula is not unreasonable, but lacks evidence showing clinical effectiveness. It is not known whether their use is cost-effective. The use of prebiotics in preventing or treating diseases in children has not been tested extensively in randomized controlled trials, but the available evidence shows possible long-term benefit for the prevention of atopic eczema and common infections in healthy infants. Confirmatory studies, especially in children who are given formula that is not partially hydrolyzed, are needed before recommendations can be made. [Dan: 2010]

Probiotics and Prebiotics in Children (AAP) reviews the known health benefits of probiotic and prebiotic products, including those added to commercially available infant formula and other food products for children.

Formula for Term Infants

Infant formulas provide for the nutritional needs of most non-breastfed infants less than 1 year old. Standard formulas contain 20 Kcal/oz and 0.45 grams of protein/oz [National: 2015] Formulas based on cow milk are appropriate for most full-term and preterm infants. The AAP recommends that all infants be fed breast milk or iron-fortified formula for at least 12 months. First year weight gain goals for most term infants are as follows:

First Year Weight Gain Goals (Birth-12 Months) for Term Infants

Age	Grams/Day
0-3 months	25-30
3-6 months	15-20
6-12 months	10-15

[Committee: 2013]

Infants with increased energy needs, history of postnatal growth restriction, or feeding difficulties may continue on a higher caloric density feeding (24 kcal/oz). [Laili: 2010] After hospital discharge, it is unclear what represents optimal growth for the preterm infant. Growth data should be plotted according to the infant’s age corrected for prematurity.

Formula for Older Children

Usually after age 1, children requiring supplemental or complete nutrition from a formula are changed from an infant formula to one designed to give a better balance of nutrition for the older child. Although childhood formulas are recommended for children ages 1-10, it may be appropriate to continue some teenagers, especially those with severe disabilities, on these formulas because they provide a better ratio of protein to overall calories. The energy and nutrient requirements of adolescents with special health care needs vary according to their individual metabolic rate, activity level, and medical status. The child or adolescent should routinely be monitored to ensure adequate nutrition for growth and development and to make adjustments for periods of stress and illness. For more details please see Childhood Formulas for Children with Disabilities (general).

Formula for Preterm and Low Birth Weight Babies

Increased calorie infant formulas:

Indications for use: Infants with low birth weight and for preterm infants
Examples: Similac Neosure Advance 22 kcal/oz, Enfamil Enfacare LIPIL 22 kcal/oz, Similac Special Care Advance 24 kcal/oz, Enfamil Premature LI PIL 24 kcal/oz

Recipes for increasing caloric density using standard 20 kcal/oz and 22 kcal/oz formulas are provided below.

Preterm formulas:

Indications for use: Formulated for preterm infants' specialized nutritional needs, which include increased protein, certain vitamins and minerals (such as calcium and phosphorus), and carbohydrates and fats designed to promote absorption (including a substantial portion of medium chain triglycerides). [Committee: 2013]
Examples: Similac Neosure Advance 22 kcal/oz, Enfamil Enfacare LIPIL 22 kc al/oz, Similac Special Care Advance 24 kcal/oz, Enfamil Premature LI PIL 24 kcal/oz

Human milk fortifiers:

Indications for use: Formulated to improve metabolic outcomes in preterm infants whose primary, long-term nutritional source is breast milk and to supply adequate protein, sodium, zinc, and facilitate bone development. They come in liquid or powder formulations that are added to breast milk. Human milk fortifiers may be found in the hospital setting; outside of the hospital setting, they typically require a prescription.
Examples: Similac Human Milk Fortifier, Prolact Human Milk Fortifier, Enfamil Human Milk Fortifier

Increasing Caloric Density - General Guide

Important recipes for increasing caloric density: When infants need extra calories to grow, the medical team can provide recipes for increasing the calories of 20 kcal/oz formulas ("term" formulas), or for 22 kcal/oz formulas (“preterm” formulas). Cost and ease of home preparation must be considered. Advise the caregiver to use precise measurements (i.e., a level scoop rather than rounded) to ensure consistent nutrition. Consult a dietician if unfamiliar with the nutritional and/or fluid requirements of your patient. If needed, contact a local NICU or children's hospital for advice.

Using Term Powder Formula to Increase Caloric Density

kcal/oz	Add one scoop of 20 kcal/oz powder formula to:
20	60 mL or 2 oz of water
22	55 mL of water
24	50 mL of water
26	45 mL of water
27	42 mL of water

+ Due to variations in formula composition, it is best to consult the manufacturer's website for more details. Powder is less accurate than liquid concentrates. [Committee: 2013]

Using Preterm Powder Formula to Increase Caloric Density for Preterm Feeding Infants

kcal/oz	Add one scoop of 22 kcal/oz premature infant powder formula to:
22	60 mL or 2 oz of water
24	55 mL of water
26	50 mL of water
27	48 mL of water

Adapted from How to Increase Calories (University of Michigan) ( PDF Document

96 KB)
+ Due to variations in formula composition, it is best to consult the manufacturer's website for more details. Powder is less accurate than liquid concentrates. [Committee: 2013]

Increasing Caloric Density Using 1 Can (13 oz) of Concentrated Liquid

kcal/oz	Add
20	13 oz water
22	11 oz water
24	9 oz water
26	7 oz water
27	6 oz water 3/4 cup

Other additives can be used to increase caloric density in special circumstances. Working with a dietician is advised for patients requiring these types of additives: [American: 2013]

Medium chain triglycerides (MCT) oil: 7.7 kcal/mL or 38 kcal/teaspoon (5 mL)
Vegetable oil: 40 kcal/teaspoon (5 mL)
Polycose powder (manufactured by Abbott Nutrition): 8 kcal/teaspoon (5 mL)

Do-It-Yourself Formulas

The American Academy of Pediatrics advises against making home-made infant formula due to serious risks of infection, ingredients that may be aspirated, and intolerance, as well as incomplete nutrition or excessive loads of certain ingredients that may be toxic. However, families may be very interested in learning more about this topic. One site with extensive information is Do-It-Yourself Baby Formulas, which is based on Weston A. Price Wise Traditions in Food, Farm, and the Healing Arts whole foods approach to diet.

Formula Funding for Children with Chronic Conditions

Cost of formula preparations, which can vary greatly, should be considered when choosing a specific formula. Formulas are generally slightly cheaper if purchased through a home care company, commissary (if a parent is in the military), or warehouses (such as Costco or Sam's Club). Store brand and generic formulas offer more reasonably priced options and have to meet the same basic requirements as name brands do.

Some insurance companies have absolute exclusions regarding formulas, while others will pay for nutritional formulas, but only after infancy, or if the formula is needed for a special diet (e.g., malabsorption or PKU).

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), for families with children under age 5, provides a limited selection of standard formulas in its formulary and requires a medical prescription with a valid diagnosis to provide alternative formulas. WIC does not necessarily cover all of the formula needed by infants, so caregivers may still be responsible for purchasing some.

Medicaid will usually fund formula if it is going through a feeding tube. Appeals may be necessary if the formula is being taken by mouth, or is not approaching 100% of the child's caloric needs. These appeals are often successful if the clinician knows Examples of Letters of Medical Necessity (Rifton). To aid in appealing an insurance company or Medicaid, it is helpful to demonstrate that the child cannot tolerate a cheaper formula first (e.g., try PediaSure first, if the child demonstrates intolerance, this information might help with the appeal for the more expensive hydrolyzed formula). Also, the diagnosis used to request the funding is important. (e.g., Medicaid may fund formula for a diagnosis of brain malformation with oral aversions, but not for a diagnosis of autism with oral aversions).

There are few mechanisms available to support those who fall between the cracks. Carnation Instant Breakfast is a cheap alternative for the child who only needs a caloric boost. A family can apply to Hospital Foundations or charity programs to help with costs, and a non-profit pharmacy may be able to provide formula at a non-profit rate. Technically, the public school system is required to supply the formula which is part of lunch (and breakfast if the child qualifies for the free breakfast program).

Brands of Formulas

Parents often ask their doctor for advice about brands. The links, below, lead to charts that list the major brands of formula and key differences among their ingredients. Formulations are generally 20 kcal/oz and contain iron, unless otherwise noted. The Medical Home Portal does not endorse a specific brand.

Although infant formulas are required to meet the requirements of the Infant Formula Act, manufacturers’ marketing claims often are not supported by clinical evidence or evaluated by the Food and Drug Administration. [Belamarich: 2015] FDA approval is only required for claims regarding formulas and their relationship to medical conditions, claims that do not reference conditions or disease (e.g., probiotics support digestive health) do not need FDA approval. [Abrams: 2015] Insufficient evidence shows that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic. [Thomas: 2010]

Examples of store brands, most of which are manufactured by Perrigo Nutritionals, are:

Parent's Choice (Walmart)
Up & Up (Target)
Babies"R"Us
Berkley Jensen (BJ's)
Comforts for Baby (Kroger)
Well Beginnings (Walgreens)
CVS
Meijer (Meijer Baby)
Member's Mark (Sam's Club)
Simply Right (Sam's Club)
Kirkland Signature (Costco)

Resources

Information & Support

For Professionals

Primary Prevention of Allergic Disease Through Nutritional Interventions: Guidelines for Healthcare Professionals (AAAAI) ( PDF Document 181 KB)
Information about food introduction and prevention of allergies and atopic dermatitis; American Academy of Allergy Asthma and Immunology.

Probiotics and Prebiotics in Children (AAP)
Reviews the currently known health benefits of probiotic and prebiotic products, including those added to commercially available infant formula and other food products for use in children; American Academy of Pediatrics.

For Parents and Patients

Support

Kids with Food Allergies (AAFA)
Provides education and an online support community for children with food allergies; a Division of the Asthma and Allergy Foundation of America.

General

Nutrient Requirements for Formula (USGS)
Provides a chart of infant formula nutrients based on the Code of Federal Regulations Title 21 Part 107; United States Federal Government.

Practice Guidelines

Fleischer DM, Spergel JM, Assa’ad AH, Pongracic JA.
Primary Prevention of Allergic Disease Through Nutritional Interventions: Guidelines for Healthcare Professionals.
American Academy of Allergy Asthma & Immunology. 1:29-36; 2013. / http://medical.gerber.com/docs/default-source/pdfs/aaaai-physician-ref...

Tools

Writing Letters of Medical Necessity provides tips for clinicians who want to write effective letters. Includes information about laying the groundwork for the appeals process.

Fluid Calculator for Children (Medscape)
Calculates typical daily and hourly fluid requirements (mL) per weight of the child.

Formulas & Fortifiers for Premature & Low Birth Weight Infants ( PDF Document 94 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Formulas for Term Infants ( PDF Document 125 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Formulas for Toddlers & Older Children ( PDF Document 168 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal, last updated December 2015.

Nutrition Issues and Concerns (Bright Futures) ( PDF Document 1.8 MB)
A Table of Selected Energy Calculations for Children and Adolescents with Special Healthcare Needs for down syndrome, spina bifida, Prader-Willi syndrome, cystic fibrosis, and pediatric HIV infection is on page 125; American Academy of Pediatrics.

Services

Helping Hands for Special Kids provides free or reduced cost specialty formula to parents who have children with special nutritional needs or parents of multiples.

For other services related to this condition, browse our Services categories or search our database.

Authors

Lead Author:

Jennifer Goldman-Luthy, MD, MRP, FAAP - 12/2015

Contributing Author:

Jessica Clayton, RDN, CDN, CLS - 11/2015

Content Last Updated:

12/2015

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American Academy of Pediatrics Committee on Nutrition; Editor in chief: Ronald E. Kleinman, MD, FAAP; Associate editor: Frank R. Greer, MD, FAAP .
Pediatric Nutrition.
7th ed. Elk Grove Village. IL: American Academy of Pediatrics; 2013. 978-1-58110-816-3 http://shop.aap.org/Pediatric-Nutrition-7th-Edition-Paperback/

Belamarich PF, Bochner RE, Racine AD.
A Critical Review of the Marketing Claims of Infant Formula Products in the United States.
Clin Pediatr (Phila). 2015. PubMed abstract

Carolyn S. Chung, PhD, Sedigheh Yamini, PhD, and Paula R. Trumbo, PhD.
FDA’s Health Claim Review: Whey-protein Partially Hydrolyzed Infant Formula and Atopic Dermatitis.
Pediatrics. 2012. / Full Text

Committee on Nutrition; Editor in chief: Ronald E. Kleinman, MD, FAAP; Associate editor: Frank R. Greer, MD, FAAP .
Pediatric Nutrition.
7th Edition ed. Elk Grove Village, IL: American Academy of Pediatrics ; 2013. 978-1-58110-816-3 http://shop.aap.org/Pediatric-Nutrition-7th-Edition-Paperback/

Dan W. Thomas, MD, Frank R. Greer, MD.
Probiotics and Prebiotics in Pediatrics.
Pediatrics. 2010;126(6). / Full Text
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Ketogenic Diet.
(2014) http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/dietary-t....

Fanni D, Ambu R, Gerosa C, Nemolato S, Iacovidou N, Van Eyken P, Fanos V, Zaffanello M, Faa G.
Aluminum exposure and toxicity in neonates: a practical guide to halt aluminum overload in the prenatal and perinatal periods.
World J Pediatr. 2014;10(2):101-7. PubMed abstract

Jatinder Bhatia, MD, Frank Greer, MD.
Use of Soy Protein-Based Formulas in Infant Feeding.
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Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, Hock QS, Jirapinyo P, Lonnerdal B, Pencharz P, Pzyrembel H, Ramirez-Mayans J, Shamir R, Turck D, Yamashiro Y, Zong-Yi D.
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Kumar M, Kabra NS, Paes B.
Carnitine supplementation for preterm infants with recurrent apnea.
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Infant Formulas.
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Probiotics and prebiotics in pediatrics.
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