Milk-based infant formulas for premature or low-birth-weight infants
Last Updated: Tuesday, December 19, 2017
Next Generation Enfamil Premature Nutrition portfolio is designed to meet the 2014 Global Expert Recommendations1 for all labeled nutrients, including:
Enfamil Premature 20 Cal is a milk-based infant formula specifically formulated to meet the unique nutritional needs of rapidly growing premature or low-birth-weight infants who do not receive human milk*. The Enfamil Premature Nutrition portfolio is the only premature infant formula line designed to meet the latest Global Expert Recommendations for all labeled nutrients. Protein is a major driver of lean mass growth and neuro-cognitive outcomes, and Enfamil Premature Nutrition supports these protein needs.
When more than 14 fl oz (414 mL) of 20 Calories/fl oz product is used per day, which may occur in larger infants weighing over 2500 g (5.5 lbs) consuming only Enfamil Premature, intake of some nutrients (eg, fat soluble vitamins) may be excessive. In such circumstances, it should be used only at the direction and under the supervision of a doctor. Enfamil® EnfaCare® may be a product to consider in such circumstances.
* Increased caloric density, protein, and some vitamins and minerals compared to standard term formula to help support weight and growth in babies born prematurely. † Whey to casein ratio 3-5 days after lactation begins. ‡ Average amount of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women4.
Product nutrient values and ingredients are subject to change.
|(Normal Dilution)||Per 100 Cal||Per 100 mL|
|Linoleic acid, mg||810||550|
|(Normal Dilution)||Per 100 Cal||Per 100 mL|
|Vitamin A, IU||1350||910|
|Vitamin D, IU||300||200|
|Vitamin E, IU||6.3||4.3|
|Vitamin K, mcg||9||6.1|
|Thiamin (Vitamin B1), mcg||200||135|
|Riboflavin (Vitamin B2), mcg||300||200|
|Vitamin B6, mcg||150||101|
|Vitamin B12, mcg||0.25||0.17|
|Folic acid (Folacin), mug||40||27|
|Pantothenic acid, mug||1200||810|
|Vitamin C (Ascorbic acid), mg||20||13.5|
|(Normal Dilution)||Per 100 Cal||Per 100 mL|
|Nutrient Density||100 Calories/fl oz|
|Protein (% Calories)||13|
|Fat (% Calories)||44|
|Carbohydrate (% Calories)||43|
|Potential Renal Solute Load (mOsm/100 Calories)8||30|
|Potential Renal Solute Load (mOsm/100 mL)8||20|
|Osmolality (mOsm/kg water)||260|
Enfamil® Premature is available in ready-to-use Nursette® bottles.
Item #: 156401
Description: RTU, 20 Cal Low Iron
Unit Size: 2 fl oz bottle
Prod. Yield / Unit (fl oz): 2
Case: 48 bottles per case
Reimbursement Code: 00087-511570
Ingredients: Ready To Use (2 fl oz Nursette bottles): Water, nonfat milk, corn syrup solids, whey protein concentrate, lactose, medium chain triglycerides (MCT oil), soy oil, high oleic sunflower oil and less than 0.5%: Mortierella alpina oil§, Crypthecodinium cohnii oil||, calcium phosphate, calcium hydroxide, potassium citrate, sodium chloride, calcium carbonate, magnesium phosphate, calcium chloride, potassium chloride, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, rice starch, sodium ascorbate, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, vitamin B12, mono- and diglycerides, inositol, soy lecithin, choline chloride, vitamin D3, nucleotides (cytidine 5’-monophosphate, disodium uridine 5’-monophosphate, adenosine 5’-monophosphate, disodium guanosine 5’-monophosphate), taurine, L-carnitine.
§ A source of arachidonic acid (ARA). || A source of docosahexaenoic acid (DHA).
Enfamil Premature contains milk and soy.
This product should be used only as directed by the baby’s doctor.
The baby's health depends on carefully following these instructions. Proper hygiene, preparation, use and storage are important when preparing infant formula.
Discuss with parents whether they need to boil a clean nipple in water before use.
Inspect each bottle for signs of damage.
Wash hands thoroughly with soap and water before preparing bottle for feeding.
SHAKE BOTTLE WELL and remove cap.
Attach nipple unit (not included).
Failure to follow these instructions could result in severe harm. Opened bottles can spoil quickly. Either feed immediately or replace cap and store in refrigerator at 35°–40°F (2°–4°C) for no longer than 24 hours. Do not use opened bottle if it is unrefrigerated for more than a total of 2 hours. Do not freeze. After feeding begins, use within 1 hour or discard.
Enfamil® Premature may be provided at full strength or diluted for initial feedings. If it is diluted, progression to full strength should be made rapidly, as tolerated. If Enfamil Premature formula is fed to very low‑birth‑weight infants or stressed low‑birth‑weight infants, some clinicians choose to dilute initial feedings to half strength (10 Calories/fl oz if 20 Calories/fl oz formula is used).
20 Calories/fl oz Formulation
|Dilution (parts of formula to parts of water)|
|Calories/mL||Calories/fl oz||PRSL19 (mOsm/100 mL)||Protein (g/100 mL)||Osmolality (mOsm/kg of water)||Osmolarity (mOsm/L)|
PRSL (mOsm/100 mL) = (mmole nitrogen/2 + mmole Na + mmole K + mmole CI + mmole P)/100 mL.
Nursette® Bottle Storage
Store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze.
Use by date on carton and bottle label.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
The fat content in Enfamil Premature is 44% of total calories. Experts recommend that both preterm and term infants receive 40%-55% of their calories from fat1,9,10. Because preterm infants may have difficulty digesting and absorbing long-chain fatty acids, medium-chain triglycerides (MCTs) are used in Enfamil Premature. The fat blend in Enfamil Premature consists of approximately:
DHA and ARA
Enfamil Premature has DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes11-18. Some studies also show that DHA and ARA may enhance growth of premature infants compared to formulas without DHA and ARA4,19. The levels of DHA and ARA in Enfamil Premature are similar to those found in average worldwide breast milk20,¶, as well as similar to the levels specified by expert groups1-3,21-23.
¶ Average level of DHA and ARA in worldwide breast milk is 0.32% ± 0.22% and 0.47% ± 0.13% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women20.
Because preterm infants may have difficulty digesting and absorbing long-chain fatty acids, 40% of the fat in Enfamil Premature is from MCTs. Medium-chain triglycerides are more rapidly and completely hydrolyzed than long-chain triglycerides, and the resulting medium-chain fatty acids are effectively absorbed by individuals with fat malabsorption24.
Protein provides 13% of total calories in Enfamil Premature. The protein is patterned after early human milk# with 80% whey and 20% casein from whey protein concentrate and nonfat milk. The level of protein is 3.3 g/100 Calories, which meets 2014 Global Expert Recommendations2.
# Whey:casein ratio of typical early breast milk (days 3-5 after lactation begins).
Carbohydrate provides 43% of total calories in Enfamil Premature. The carbohydrate is a blend of 60% corn syrup solids (glucose polymers) and 40% lactose. The carbohydrate blend helps avoid overloading the infant's capacity to digest lactose. Low-birth-weight infants can readily digest the corn syrup solids used in Enfamil Premature.
Vitamins and Minerals
Vitamin and mineral levels are designed to help meet recent expert recommendations for preterm infants1-3.
Calcium and Phosphorus
Enfamil Premature provides 165 mg calcium/100 Calories and a calcium:phosphorus ratio of 1.83:1, similar to that of human milk. The low-birth-weight infant requires greater amounts of calcium to meet dietary requirements than is provided by human milk or standard infant formulas1,2. Calcium supplementation to standard infant formulas has been shown to improve calcium status of low-birth-weight infants25.
Enfamil Premature with Iron at 20 Calories/fl oz contains 12.2 mg iron/L to help prevent iron deficiency and reduce the need for supplemental iron.
Electrolytes—Sodium, Potassium, and Chloride
The electrolyte levels in Enfamil Premature reflect recommendations of experts2,3. The sodium, potassium, and chloride levels are 70 mg/100 Calories, 98 mg/100 Calories, and 106 mg/100 Calories, respectively.
The nucleotide levels in Enfamil Premature are patterned after the average level of free nucleotides found in breast milk (28 mg/L)7-10. At 20 Calories/fl oz, Enfamil Premature provides 28 mg free nucleotides/L.
Clinical studies with Enfamil Premature demonstrate that the formula promotes growth, is well tolerated, and is safe.4,19, In addition, in one study, premature infants fed Enfamil formulas with DHA and ARA had higher scores on a test of infant development than similar infants fed unsupplemented formulas19,††.
**Studies used Enfamil Premature, Enfamil EnfaCare, and Enfamil® Infant. †† Studies used Enfamil Premature, Enfamil EnfaCare, and Enfamil LIPIL®
Preterm infants who received Enfamil Premature, Enfamil EnfaCare, and Enfamil Infant: Achieved higher scores on both the MDI and PDI of the Bayley Scales of Infant Development II vs infants receiving the discontinued formulas without DHA and ARA‡‡.
Mean Scores on Bayley Scales of Infant Development II at 18 months Corrected Age4,§§
‡‡ Study was conducted prior to the reformulation of Enfamil Premature to meet 2014 Global Expert Recommendations. §§ Some infants in this study were fed formulas supplemented with DHA from a fish source, but data are not shown in the graph. From a randomized, double-blind, multicenter trial involving 245 VLBW infants.
One study evaluated premature infants who had received Enfamil formulas until they were 1 year CA. In the randomized, double-blind, prospective, multi-center trial, very low-birth-weight (VLBW) infants were assigned to one of 3 formula groups: formulas with no DHA and ARA; formulas with DHA from fish oil and ARA from single-cell oil; or formulas with DHA and ARA from single-cell oil. Each formula group included a premature formula (24 Calories/fl oz)||||, a nutrient enriched discharge formula (22 Calories/fl oz), and a term formula (20 Calories/fl oz). The investigators involved in the study chose when each formula type (premature, discharge, or term formula) was fed to the infants. Formulas were the only source of diet until 4 months CA and were fed until 12 months CA. Between 12 months CA and 18 months CA, infants were fed diets determined by their parents. Term infants (n=105) who were to receive breast milk for 4 months served as a reference group. The study found that the group of infants that received premature, discharge, and term formulas with single cell oil source of DHA and ARA had significantly greater achieved weight from 6 through 18 months CA when compared to infants who received formula without DHA and ARA. The weight of the infants in the study group was comparable to that of full-term breastfed infants at 18 months CA. Infants in the DHA and ARA supplemented group also had a significantly greater achieved length at 2, 9, and 12 months CA than infants who received discontinued formula without DHA and ARA19.
Additionally infants fed Enfamil Premature experienced enhanced growth when compared with infants who received Enfamil Premature formula without DHA. In a double-blind, multi-center study, 194 premature infants received formula with no DHA and ARA (Enfamil Premature formula), formula with DHA only, or Enfamil Premature formula with 17 mg DHA and 34 mg ARA/100 Calories|||| for at least 28 days during hospitalization. The infants who received Enfamil Premature with DHA and ARA gained weight significantly faster during hospitalization than infants who received formula with no DHA and ARA. In addition, the group that was fed formulas with DHA and ARA had weights and weight:length ratios that were similar to term breastfed infants at 1 and 4 months CA4.
|||| Study was conducted prior to the reformulation of Enfamil Premature to meet 2014 Global Expert Recommendations.
Growth of Premature Infants Fed Enfamil Infant Formulas19
§§ P<0.05 for breastfed, full-term infants vs all preterm groups. |||| No significant difference (P>0.05) for Enfamil Infant formulas vs breastfed, full-term infants, but P<0.05 for control formulas vs breastfed, full-term infants. ¶¶ P<0.05 for control formulas vs Enfamil Infant formulas. ## Enfamil Premature, Enfamil EnfaCare, and Enfamil Infant.
From a randomized, double-blind, multicenter trial involving 245 VLBW infants and 105 breastfed, full-term infants. Some infants in this study were fed formulas supplemented with DHA from a fish source, but data are not shown in the graph.
Preterm infants who received Enfamil Premature, Enfamil EnfaCare, and Enfamil Infant:
Safety and Tolerance
In both studies described above, formulas with DHA and ARA were well tolerated by premature infants4,22. The addition of DHA and ARA in the formula had no effect on the incidence of adverse events in either study4,19,**.
** Study was conducted prior to the reformulation of Enfamil Premature to meet 2014 Global Expert Recommendations.
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2. Klein CJ. Nutrient requirements for preterm infant formulas. J Nutr. 2002;132(suppl):1395S-1577S.
3. Agostoni C, Buonocore G, Carnielli VP, et al. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010;50:85-91.
4. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.
5. Innis SM, Adamkin DH, Hall RT, et al. Docosahexaenoic acid and arachidonic acid enhance growth with no adverse effects in preterm infants fed formula. J Pediatr. 2002;140:547-554.
6. Tantibhedhyangkul P, Hashim SA. Medium-chain triglyceride feeding in premature infants: effects on fat and nitrogen absorption. Pediatrics. 1975;55:359-370.
7. Andrews BF, Lorch V. Improved fat and Ca absorption in LBW infants fed a medium-chain triglyceride containing formula [abstract]. Pediatr Res. 1974;8:104.
8. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
9. Assessment of nutrient requirements for infant formulas. J Nutr. 1998; 128:i-iv, 2059S-2293S.
10. National Academy of Sciences. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academies Press; 2005.
11. Birch EE, Hoffman DR, Uauy RD, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201-209.
12. Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174-181.
13. Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.
14. Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASEB J. 2003;17:A727-A728. Abstract 445.1.
15. Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.
16. Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.
17. Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.
18. Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.
19. Clandinin MT, Van Aerde JE, Merkel KL, et al. Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. J Pediatr. 2005;146:461-468.
20. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr 2007;85:1457-1464.
21. The British Nutrition Foundation. Recommendations for intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and physiological significance: The Report of the British Nutrition Foundation’s Task Force. London: Chapman & Hall; 1992:152-163.
22. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;18:487-489.
23. Koletzko B, Agostoni C, Carlson SE, et al. Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.
24. Bach AC, Babayan VK. Medium-chain triglycerides: an update. Am J Clin Nutr. 1982;36:950-962.
25. Day GM, Chance GW, Radde IC, et al. Growth and mineral metabolism in very low birth weight infants. II. Effects of calcium supplementation on growth and divalent cations. Pediatr Res. 1975;9:568-575.