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Formulas

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Overview

While breast milk is recommended for most infants during the first 6-12 months of life or longer, formula is often used in infancy when breast milk is not available or contraindicated. Formula is also given to older children who are unable to obtain adequate nutrition through conventional means. This page informs clinicians about the different types of formulas for premature infants, term infants, and older children and includes information about adjusting caloric density and selecting different formula types. For ideas about obtaining financial help with purchasing formulas for children with special health care needs, see Formula Funding.

Formula Basics

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
Premature Infant with Jaundice Drinking Formula from a Bottle
AJPhoto/Science Photo Library 		Formulas are made of 6 basic components - protein, fat, carbohydrate, vitamins, minerals, and other nutrients. Details about the components that make up formula can be found on the Portal at Formula Ingredients and Components. What makes formulas unique are the specific carbohydrates, fats, and proteins used, as well as any additional ingredients added. These differences and their indicated use are explained below. International recommendations for formula composition can be found at [Koletzko: 2005].

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 the child's age 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. The Medical Home Portal does not endorse a specific brand or preparation; but, commercially prepared formulas will be mentioned here to provide examples.

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, a 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.
Major brands of formula and key differences among their ingredients are listed below. The Medical Home Portal does not endorse a specific brand or preparation; but, commercially prepared formulas will be mentioned here to provide examples.

Formula for Preterm and Low Birth Weight Babies

Increased calorie infant formulas:
  • Indications for use: Infants with low birth weight and 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 infant 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, to supply adequate protein, sodium, zinc, and to facilitate bone development. Liquid or powder formulations 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
Major brands of formula and key differences among their ingredients are listed below. The Medical Home Portal does not endorse a specific brand or preparation; but, commercially prepared formulas will be mentioned here to provide examples.

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 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 during periods of stress and illness.
Major brands of formula and key differences among their ingredients are listed below. The Medical Home Portal does not endorse a specific brand or preparation; but, commercially prepared formulas will be mentioned here to provide examples.

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).

Advise the caregiver to use precise measurements (e.g., 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. Cost and ease of home preparation must be considered.

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. [American: 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. [American: 2013]

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.
Many families of children with special health needs also develop blenderized diets for tube feeding. These consist of taking a wholesome diet and blending it into a consistency that can be administered through a feeding tube. Consulting with a dietician is advised for families who wish to pursue blenderized feeding instead of, or in addition to, formula.

Brands of Formulas

Parents often ask their doctor for advice about brands. The following links lead to charts that list many brands of formula and key differences among their ingredients. 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 benefit infants with fussiness, gas, or colic; [Thomas: 2010] [Sung: 2018] however, ongoing research suggests that various combinations of these may provide benefit for certain conditions such as constipation and prevention of eczema.
Examples of store brands, most of which are manufactured by Perrigo Nutritionals, are:
  • Babies"R"Us
  • Berkley Jensen (BJ's)
  • Comforts for Baby (Kroger)
  • CVS Health
  • Kirkland Signature (Costco)
  • Meijer (Meijer Baby)
  • Member's Mark (Sam's Club)
  • Parent's Choice (Walmart)
  • Simply Right (Sam's Club)
  • Up & Up (Target)
  • Well Beginnings (Walgreens)

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. Continuation of preterm infant formulas 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 recommended intakes for fat-soluble vitamins.

Formula feeding contraindications
Contraindications 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]

Resources

Information & Support

Formula Ingredients and Components
Detailed information about differences in the basic components of formulas and the indicated use for the different formula types.

Formula Funding
Information about obtaining financial help with purchasing formulas for children with special health care needs.

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 Pediatrics (AAP)
Reviews of 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)
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...

Sampson HA, Aceves S, Bock SA, James J, Jones S, Lang D, Nadeau K, Nowak-Wegrzyn A, Oppenheimer J, Perry TT, Randolph C, Sicherer SH, Simon RA, Vickery BP, Wood R, Bernstein D, Blessing-Moore J, Khan D, Lang D, Nicklas R, Oppenheimer J, Portnoy J, Randolph C, Schuller D, Spector S, Tilles SA, Wallace D, Sampson HA, Aceves S, Bock SA, James J, Jones S, Lang D, Nadeau K, Nowak-Wegrzyn A, Oppenheimer J, Perry TT, Randolph C, Sicherer SH, Simon RA, Vickery BP, Wood R.
Food allergy: a practice parameter update-2014.
J Allergy Clin Immunol. 2014;134(5):1016-25.e43. PubMed abstract

Patient Education

Let's Talk about Infant Formula Basics (Intermountain Healthcare) (PDF Document 392 KB)
A printable patient handout that explains formula selection, preparation, and storage.

Let's Talk about Infant Formula Basics (Spanish) (Intermountain Healthcare) (PDF Document 163 KB)
A printable patient handout in Spanish that explains formula selection, preparation, and storage.

Tools

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

Formulas and Fortifiers for Premature and 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.

Formulas for Metabolic Conditions (PDF Document 138 KB)
A chart that lists the major brands of formula and the key differences among their ingredients.

Formulas for Term Infants (PDF Document 265 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal.

Formulas for Toddlers & Older Children (PDF Document 296 KB)
A chart that lists the major brands of formula and the key differences among their ingredients; created by the Medical Home Portal.

Nutrition Issues and Concerns (Bright Futures) (PDF Document 1.8 MB)
Detailed guidance on breastfeeding and nutritional issues for children with special health care needs. A table with energy calculations for children and adolescents with Down syndrome, spina bifida, Prader-Willi syndrome, cystic fibrosis, and pediatric HIV infection is on page 125; American Academy of Pediatrics.

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Helpful Articles

Hojsak I, Bronsky J, Campoy C, Domellöf M, Embleton N, Fidler Mis N, Hulst J, Indrio F, Lapillonne A, Mølgaard C, Vora R, Fewtrell M.
Young Child Formula: A Position Paper by the ESPGHAN Committee on Nutrition.
J Pediatr Gastroenterol Nutr. 2018;66(1):177-185. PubMed abstract

Martin CR, Ling PR, Blackburn GL.
Review of Infant Feeding: Key Features of Breast Milk and Infant Formula.
Nutrients. 2016;8(5). PubMed abstract / Full Text

Molska A, Gutowska I, Baranowska-Bosiacka I, Noceń I, Chlubek D.
The content of elements in infant formulas and drinks against mineral requirements of children.
Biol Trace Elem Res. 2014;158(3):422-7. PubMed abstract / Full Text

Chung CS, Yamini S, Trumbo PR.
FDA's health claim review: whey-protein partially hydrolyzed infant formula and atopic dermatitis.
Pediatrics. 2012;130(2):e408-14. PubMed abstract

Jatinder Bhatia, MD, Frank Greer, MD.
Use of Soy Protein-Based Formulas in Infant Feeding.
Pediatrics. 2008;121(5). PubMed abstract / Full Text

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.
Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group.
J Pediatr Gastroenterol Nutr. 2005;41(5):584-99. PubMed abstract

Kumar M, Kabra NS, Paes B.
Carnitine supplementation for preterm infants with recurrent apnea.
Cochrane Database Syst Rev. 2004(4):CD004497. PubMed abstract

Laili Abd Latif, M et al.
Nutrition Interventions for Children with Special Health Care Needs.
2010; 3rd:441. Washington: Washington Department of State Health; https://www.doh.wa.gov/Portals/1/Documents/8100/961-158-CSHCN-NI-en-L....

National Institutes of Health.
Infant Formulas.
U.S. National Library of Medicine; (2015) http://www.nlm.nih.gov/medlineplus/ency/article/002447.htm. Accessed on August 2018.

Singhal A, Kennedy K, Lanigan J, Clough H, Jenkins W, Elias-Jones A, Stephenson T, Dudek P, Lucas A.
Dietary nucleotides and early growth in formula-fed infants: a randomized controlled trial.
Pediatrics. 2010;126(4):e946-53. PubMed abstract

Verner A, Craig S, McGuire W.
Effect of taurine supplementation on growth and development in preterm or low birth weight infants.
Cochrane Database Syst Rev. 2007(4):CD006072. PubMed abstract

Authors & Reviewers

Initial publication: June 2018; last update/revision: August 2018
Current Authors and Reviewers:
Authors: Jennifer Goldman-Luthy, MD, MRP, FAAP
Lynne M. Kerr, MD, PhD
Reviewer: Jessica Clayton, RDN, CDN, CLS

Page Bibliography

Abrams SA.
Is it time to put a moratorium on new infant formulas that are not adequately investigated?.
J Pediatr. 2015;166(3):756-60. PubMed abstract

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

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/

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

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.
Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group.
J Pediatr Gastroenterol Nutr. 2005;41(5):584-99. PubMed abstract

Laili Abd Latif, M et al.
Nutrition Interventions for Children with Special Health Care Needs.
2010; 3rd:441. Washington: Washington Department of State Health; https://www.doh.wa.gov/Portals/1/Documents/8100/961-158-CSHCN-NI-en-L....

National Institutes of Health.
Infant Formulas.
U.S. National Library of Medicine; (2015) http://www.nlm.nih.gov/medlineplus/ency/article/002447.htm. Accessed on August 2018.

Sung V, D'Amico F, Cabana MD, Chau K, Koren G, Savino F, Szajewska H, Deshpande G, Dupont C, Indrio F, Mentula S, Partty A, Tancredi D.
Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis.
Pediatrics. 2018;141(1). PubMed abstract

Thomas DW, Greer FR.
Probiotics and prebiotics in pediatrics.
Pediatrics. 2010;126(6):1217-31. PubMed abstract / Full Text