Preterm nutrition products
Benefits of an Exclusive Human Milk Diet (EHMD)
More than 20 clinical studies with more than 5,000 premature infants have demonstrated the effectiveness of Prolacta’s 100% human milk-based nutritional products.1 Data on file.
Our products, as part of an exclusive human milk diet, have been shown in clinical studies to:
- Significantly reduce the risk of complications and feeding intolerance associated with cow milk-based fortifiers2
Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
,3Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024
,4Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595. doi:10.1016/j.jpeds.2013.07.011
,5Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567. doi:10.1016/j.jpeds.2009.10.040
- Fortify early to safely nourish the preterm infant to ensure healthy gut, lung and brain development, as well as achieve healthy growth6
Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
,7Huston RK, Lee ML, Rider ED, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2019. [Epub ahead of print]. doi:10.3233/NPM-190300
,8Hair AB, Bergner EM, Gollins LA, et al. Long-term outcomes at 2 and 5 years from the randomized controlled trial: human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in VLBW infants. Poster presented at: Pediatric Academic Societies Meeting. April 24 – May 1, 2019. Baltimore, MD.
Our products
Prolacta’s human milk-based nutritional products contain a wide range of human milk oligosaccharides (HMOs) – special sugars abundantly found in human milk.9 Barile D, Lebrilla CB, German B, Rechtman DJ, Lee ML. Oligosaccharide prebiotics present in a breast milk based human milk fortifier. Presented at Hot Topics in Neonatology. Washington DC December 2008 Smilowitz JT, Lebrilla CB, Mills DA, German JB, Freeman SL. Breast milk oligosaccharides: structure-function relationships in the neonate. Annu Rev Nutr. 2014;34:143-169. doi:10.1146/annurev-nutr-071813-105721 Ruhaak LR, Stroble C, Underwood MA, Lebrilla CB. Detection of milk oligosaccharides in plasma of infants. Anal Bioanal Chem. 2014;406(24):5775-5784. doi:10.1007/s00216-014-8025-z
Humavant+
Humavant+ is the first commercially available human milk fortifier made from 100% human milk.
- Intended for premature/low birthweight infants (weighing under 1,500g at birth)
- Helps to ensure healthy gut, lung and brain development, as well as achieve healthy growth6
Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
,7Huston RK, Lee ML, Rider ED, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2019. [Epub ahead of print]. doi:10.3233/NPM-190300
,8Hair AB, Bergner EM, Gollins LA, et al. Long-term outcomes at 2 and 5 years from the randomized controlled trial: human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in VLBW infants. Poster presented at: Pediatric Academic Societies Meeting. April 24 – May 1, 2019. Baltimore, MD.
- Retains human milk oligosaccharide content similar to that of fresh human milk9
Barile D, Lebrilla CB, German B, Rechtman DJ, Lee ML. Oligosaccharide prebiotics present in a breast milk based human milk fortifier. Presented at Hot Topics in Neonatology. Washington DC December 2008
HumavantTM CR Human Milk Caloric Fortifier
Human milk caloric fortifier is ideal for neonatal infants receiving low caloric content. Data show that 65% of the time, term mother’s own milk (MOM) is less than 20 Cal/30 ml.12 Wojcik K, et al. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009;109(1):137-140. doi:10.1016/j.jada.2008.10.008.
- Intended for use with MOM or donor milk (DM) to increase lipids and achieve adequate growth
- Formulated to deliver at least 2.6 Cal/ml
- Available frozen in 30 ml bottles containing 10 ml of product
(4 bottles per unit carton, with 48-hour expiration) - Includes simplified preparation instructions
- Easy to use and measure
Humavant CR human milk caloric fortifier is the only completely human solution created to add calories to MOM or DM without substantially increasing volume and without introducing a non-human milk-based nutritional product.
A randomised clinical trial found that premature infants, who received an exclusive human milk diet (EHMD) with Humavant CR fortifier, had superior length and weight velocity compared to infants who received an EHMD without Humavant CR fortifier.13 Hair AB, et al. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. November 2014;165(5):915-20. doi:10.1016/j.jpeds.2014.07.005.
Preterm infants who received Humavant CR fortifier had a significantly earlier post-menstrual age (PMA) at discharge and trended toward decreased length of stay when compared to those who did not receive Humavant CR fortifier.14 Hair AB, et al. Premature infants 750-1250 g birth weight supplemented with a novel human milk-derived cream are discharged sooner. Breastfeed Med. 2016;11(3):133-137. doi:10.1089/bfm.2015.0166 Results were significant after adjusting for whether the baby had BPD, their gestational age, and their birth weight.
This study is a subset analysis of data originally published in 2014 by Hair et al in The Journal of Pediatrics.
Clinical Studies and Publications:
- Randomised Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1,250 g Birth Weight
- Premature Infants 750–1,250g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner
- Fortifier and Cream Improve Fat Delivery in Continuous Enteral Infant Feeding of Breast Milk
- Macronutrient analysis of a nationwide sample of donor breast milk
Product information downloads
Overcoming complications
Prolacta’s products, when used as part of an exclusive human milk diet, have been shown to reduce the incidence of clinical complications.
In a multicentre, retrospective cohort study with 1,587 patients, the outcomes of extremely premature infants (< 1,250 g birthweight) who received a diet including cow’s milk-based products were compared with infants who received an EHMD. The incidence of mortality, necrotising enterocolitis (NEC), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) and late-onset sepsis were all reduced with an EHMD.13 Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134. Published correction appears in Breastfeed Med. 2017;12(10):663. doi:10.1089/bfm.2015.0134.correx
Improving outcomes with Prolacta's exclusive human milk diet
- Decreasing feeding intolerance – Prolacta's EHMD was associated with a lower incidence of feeding intolerance and shorter time to full feeds compared to a diet containing cow milk-based products2
Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
- Supporting adequate growth – An EHMD feeding protocol for infants with a birthweight of ≤1250 g that enables early and rapid fortification advancement is associated with weight, length and head circumference gains meeting targeted standards, and with a low rate of extrauterine growth restriction6
Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
,7Huston RK, Lee ML, Rider ED, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2019. [Epub ahead of print]. doi:10.3233/NPM-190300
,13Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134. Published correction appears in Breastfeed Med. 2017;12(10):663. doi:10.1089/bfm.2015.0134.correx
- Turning to nutrition to address the complications of prematurity – Today, more and more hospitals are turning to Prolacta’s fortifiers that are clinically proven as part of an EHMD; this nutritional solution is shown in a growing body of evidence to reduce the most serious complications of prematurity2
Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
,7Huston RK, Lee ML, Rider ED, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2019. [Epub ahead of print]. doi:10.3233/NPM-190300
,14Hair AB. Evaluation of the Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants. ClinicalTrials.gov identifier: NCT0247543. June 10, 2015. Updated December 24, 2019. Accessed May 19, 2020. https://clinicaltrials.gov/ct2/show/NCT02475434
,16Visuthranukul C, Abrams SA, Hawthorne KM, Hagan JL, Hair AB. Premature small for gestational age infants fed an exclusive human milk-based diet achieve catch-up growth without metabolic consequences at 2 years of age. Arch Dis Child Fetal Neonatal Ed. 2019;104(3);F242–F247. doi:10.1136/archdischild-2017-314547
Reducing hospital costs with an EHMD
Very low birthweight babies are at risk for prematurity-related morbidities and interventions, such as BPD, ROP, late-onset sepsis and NEC. The incremental cost of these morbidities and interventions can substantially increase the cost of NICU hospitalisation.
‘Despite the added cost of donor human milk and donor milk-derived fortifier, an EHMD is cost-effective.’2M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
Citations
1 Data on file.
2 Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
3 Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024
4 Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595. doi:10.1016/j.jpeds.2013.07.011
5 Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567. doi:10.1016/j.jpeds.2009.10.040
6 Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
7 Huston RK, Lee ML, Rider ED, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk based fortifier. J Neonatal Perinatal Med. 2019. [Epub ahead of print]. doi:10.3233/NPM-190300
8 Hair AB, Bergner EM, Gollins LA, et al. Long-term outcomes at 2 and 5 years from the randomized controlled trial: human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in VLBW infants. Poster presented at: Pediatric Academic Societies Meeting. April 24 – May 1, 2019. Baltimore, MD.
9 Barile D, Lebrilla CB, German B, Rechtman DJ, Lee ML. Oligosaccharide prebiotics present in a breast milk based human milk fortifier. Presented at Hot Topics in Neonatology. Washington DC December 2008
10 Smilowitz JT, Lebrilla CB, Mills DA, German JB, Freeman SL. Breast milk oligosaccharides: structure-function relationships in the neonate. Annu Rev Nutr. 2014;34:143-169. doi:10.1146/annurev-nutr-071813-105721
11 Ruhaak LR, Stroble C, Underwood MA, Lebrilla CB. Detection of milk oligosaccharides in plasma of infants. Anal Bioanal Chem. 2014;406(24):5775-5784. doi:10.1007/s00216-014-8025-z
12 Wojcik K, et al. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009;109(1):137-140. doi:10.1016/j.jada.2008.10.008.
13 Hair AB, et al. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. November 2014;165(5):915-20. doi:10.1016/j.jpeds.2014.07.005.
14 Hair AB, et al. Premature infants 750-1250 g birth weight supplemented with a novel human milk-derived cream are discharged sooner. Breastfeed Med. 2016;11(3):133-137. doi:10.1089/bfm.2015.0166
15 Results were significant after adjusting for whether the baby had BPD, their gestational age, and their birth weight.
16 Visuthranukul C, Abrams SA, Hawthorne KM, Hagan JL, Hair AB. Premature small for gestational age infants fed an exclusive human milk-based diet achieve catch-up growth without metabolic consequences at 2 years of age. Arch Dis Child Fetal Neonatal Ed. 2019;104(3);F242–F247. doi:10.1136/archdischild-2017-314547
