Scientific Evidence:

Publications on NeoLacta’s Products:

  1. Bharadwaj, N., Panigrahy, N., Bagga, N. et al. “Human Milk–Derived Fortifier as Rescue Therapy in Very Preterm Infants Intolerant to Cow’s Milk–Derived Fortifier” . Indian J Pediatr (2022).
  2. Gowtham R, Afza A, Shankar, Subbanna L. An open-label, pilot study to evaluate the benefits of using lyophilized human milk-derived nutritional product (NeoLact 70 – 1.55 g) as an immune-nutritional supplement in premature infants discharged from NICU. Indian J Child Health. 2021;December 29 [Epub ahead of print].
  3. Kotha, R., Konda, K. C., Pandala, P., & Maddireddi, A. (2021). Effect of human milk enriched with human milk-based fortifier (HMBF) versus bovine milk-based fortifier (BMBF) on growth and morbidity among very low birth weight (VLBW) infants – A randomized controlled trial. Journal of Pediatric and Neonatal Individualized Medicine (JPNIM), 11(1), e110104.
  4. Wazir, S., Ershad Mustafa, S., & Reddy, V. (2021). 100% human milk diet: an integral part of nutrition management in NICU: PAN India neonatologist’s survey. International Journal of Contemporary Pediatrics, 8(3), 445-450. 
  5. Halkar MP, et al. Effect of Early Fortification With 100% Human Milk–Derived Fortifier on Preterm Neonates. PERINATOLOGY Jul–Sep 2020; 21 (2): 57-63.
  6. Sahni M, Chandra P, Sharma DM, Pejaver RK, Thomas B, Cardoza F, Vikram Reddy K., Benefits of 100% human milk diet in preterm infants: NICU Nurses Survey. Pediatric Rev Int J Pediatr Res. 2020;7(6): 248-254.
  7. Joy, A. (2021). Clinical impact of using a human milk-based fortifier in a preterm infant demonstrating intolerance to bovine milk-based fortifiers – A case report.
  8. Pejaver RK, Maneesha PH, Lingaraju S. Pejaver, R. K., Maneesha, P. H., & Lingaraju, S. Effect of 100% human milk-derived fortifier on growth of premature infants with birth weight of 1000–1500 g. Indian Journal of Child Health, 7(1), 33-35.

Benefits of Human Milk

  1. Hair A, et al. “Human milk feeding supports adequate growth in infants < 1250 grams birth weight” BMC Research Notes. 13 November 2013; doi:10.1186/1756-0500-6-459.
  2. Bertino E, Giuliani F, Baricco M, et al. “Benefits of donor milk in the feeding of preterm infants.” Early Hum Dev.October 2013; 89 Suppl 2:S3-6 | doi:10.1016/j.earlhumdev.2013.07.008.
  3. Underwood MA. “Human milk for the premature infant.” Pediatr Clin North Am. February 2013; 60(1):189-207 | doi:10.1016/j.pcl.2012.09.008.
  4. Bhatia J. “Human milk and the premature infant.” Perinatology. 2007; 27, S71–S74 | doi:10.1038/sj.jp.7211713
  5. Schanler RJ, Hurst NM, Lau C. “The use of human milk and breastfeeding in premature infants.” Clin. Perinatol.1999; 26; 370-398.
  6. Hair A, et al. “Premature Infants 750–1,250g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner.” Breastfeeding Medicine. April 2016; 11(3): 133-137 | doi:10.1089/bfm.2015.0166.
  7. Wang Y, Wu S. “The effect of exclusive breastfeeding on development and incidence of infections in infants.” J Hum Lact. 1996; 12: 27.
  8. Das BK, Mishra RN, Mishra OP, Bhargava V, Prakash A. “Comparative outcome of low birth weight babies.Indian Pediatr”. 1993 Jan;30(1):15-21.
  9. Bharati P, Pal M, Bandyopadhyay M, Bhakta A, Chakraborty S, Bharati P. “Prevalence and causes of low birth weight in India”. Malays J Nutr 2011 Dec;17(3):301-13.
  10. Arslanoglu S, Moro GE, Bellu R, Turoli D, De NG, Tonetto P, et al. “Presence of human milk bank is associated with elevated rate of exclusive breastfeeding in VLBW infants”. J Perinat Med 2013 Mar;41(2):129-31
  11. De NG, Berti M, De NM, Bertino E. “Early enteral feeding with human milk for VLBW infants”. J Biol Regul Homeost Agents 2012 Jul;26(3 Suppl):69-73.
  12. Israel-Ballard K, Donovan R, Chantry C, Coutsoudis A, Sheppard H, Sibeko L, et al. “Flash-heat inactivation of HIV-1 in human milk: a potential method to reduce postnatal transmission in developing countries”. J Acquir Immune Defic Syndr 2007 Jul 1;45(3):318-23.
  13. Lucas A, Morley R, Cole TJ. “Randomised trial of early diet in preterm babies and later intelligence quotient.” BMJ. 28 Nov 1998; 317(7171): 1481–1487.
  14. Hair A, et al. “Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk–Based Diet.” Breastfeeding Medicine. March 2016; 11(2): 70-74 | doi:10.1089/bfm.2015.0134.
  15. Lönnerdal B. Nutritional and physiologic significance of human milk proteins. Am J Clin Nutr. 2003;77(6):1537S–1543S.
  16. Barłowska J, et al. Nutritional value and technological suitability of milk from various animal species used for dairy production. Compr Rev Food Sci Food Safety. 2011;10(6):291–302.
  17. Zhang M. Nutrition of Breast Milk Components in Humans. EC Nutrition. 2017; 10.6:224–227.
  18. Jantscher-Krenn E, Bode L. Human milk oligosaccharides and their potential benefits for the breast-fed neonate. Minerva Pediatr. 2012;64(1):83–99.
  19. Pozzo L, et al. Comparison of oxidative status of human milk, human milk fortifiers and preterm infant formulas. Foods. 2019;8(10):458.
  20. Layman DK, Lönnerdal B, Fernstrom JD. Applications for α-lactalbumin in human nutrition. Nutr Rev. 2018;76(6):444–460

100% Human Milk Diet vs Formula

  1. Cristofalo EA, Schanler RJ, Blanco CL, et al. “Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants.” The Journal of Pediatrics. December 2013;163(6):1592-1595 | doi: 10.1016/j.jpeds.2013.07.011
  2. Abrams SA, Schanler RJ, Lee ML et al. “Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products.” Breastfeeding Medicine June 2014; 9(6): 281-285 | doi:10.1089/bfm.2014.0024.
  3. Boyd CA, Quigley MA and Brocklehurst P. “Donor breast milk versus infant formula for preterm infants: systematic review and meta-analysis.” Arch Dis Child Fetal Neonatal Ed.. 2007; 92:3 F158-F159 | doi:10.1136/adc.2005.089490.
  4. Schanler RJ, Lau C, Hurst NM, Smith OE. “Randomized trial of donor human milk versus preterm formula as substitutes for mothers’ own milk in the feeding of extremely premature infants.” Pediatrics. August 2005; 116(2):400-6 | doi: 10.1542/peds.2004-1974.
  5. McGuire W, Anthony MY. “Donor human milk versus formula for preventing necrotizing enterocolitis in preterm infants: systematic review.” Arch Dis Child Fetal Neonatal Ed.. 2003; 88:F11-F14.
  6. Dewey K, Heinig J, Nommsen-Rivers L. “Differences in morbidity between breast-fed and formula-fed infants.” J Pediatr. 1995; 126:696.
  7. Narayanan I, Murthy NS, Prakash K, et al. “Randomised controlled trial of effect of raw and holder pasteurised human milk and of formula supplements on incidence of neonatal infection.” Lancet. 1984 Nov 17;2(8412):1111-3.
  8. Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, et al. “Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants”. J Pediatr. 2013 Dec;163(6):1592-1595.

Fortification

  1. Tabata M, et al. “Fortifier and Cream Improve Fat Delivery in Continuous Enteral Infant Feeding of Breast Milk.” Nutrients. 11 February 2015; 7(2), 1174-1183 | doi:10.3390/nu7021174.
  2. Schanler RJ. “Fortified human milk: nature’s way to feed premature infants.” BMJ. 1998 Mar;14(1):5-11.
  3. Lucas A, Fewtrell M, Morley R, et al. “Randomized outcome trial of human milk fortification and developmental outcome in preterm infants.” American Journal of Clinical Nutrition. August 1996; 64(2):142-51.
  4. Narayanan I, Prakash K, Bala S, et al. “Partial supplementation with expressed breast-milk for prevention of infection in low-birth-weight infants.” Lancet. 1980 Sep 13;2(8194):561-3.
  5. Arslanoglu S, et al. Fortification of human milk for preterm infants: update and recommendations of the European Milk Bank Association (EMBA) working group on human milk fortification. Front Pediatr. 2019;7:76.
  6. Halleux VD, Rigo J. Variability in human milk composition: benefit of individualized fortification in very-low-birth-weight infants. Am J Clin Nutr. 2013;98(2):529S–535S.
  7. Bertino E, et al. New human milk fortifiers for the preterm infant. J Pediatr Neonat Individual Med. 2017;6(1):e060124.
  8. Rochow N, Fusch G, Ali A, Fusch C. O-122 Target fortification (tfo) of breast milk with fat, protein, and carbohydrates for preterm infants: influence of commercially available fortifiers on macronutrient intake. Arch Dis Child. 2014;99(Suppl 2):A71–A72.
  9. Reali A, et al. Fortification of maternal milk for very low birth weight (VLBW) pre-term neonates. Early Hum Dev. 2010;86(Suppl 1):33–36.
  10. Agostoni C, et al; ESPGHAN Committee on Nutrition. 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(1):85–91.
  11. Embleton ND, et al. Effectiveness of human milk-based fortifiers for preventing necrotizing enterocolitis in preterm infants: case not proven. Breastfeed Med. 2013;8(4):421.
  12. Chan GM, Lee ML, Rechtman DJ. Effects of a human milk-derived human milk fortifier on the antibacterial actions of human milk. Breastfeed Med. 2007;2(4): 205–208.

Cost-Benefit

  1. Goldstein M. “The Value of Human Milk Access for Premature Infants.” Institute for Patient Access. December 2015.
  2. Assad M, et al. “Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet.” Journal of Perinatology. 12 November 2015 | doi:10.1038/jp.2015.168.
  3. Patel AL, Johnson TJ, Engstrom JL, et al. “Impact of Early Human Milk on Sepsis and Health Care Costs in Very Low Birth Weight Infants.” J Perinatol. July 2013; 33(7):514-9. | doi: 10.1038/jp.2013.2.
  4. Ganapathy V, Hay JW, Kim JH. “Costs of Necrotizing Enterocolitis and Cost-Effectiveness of Exclusively Human Milk-Based Products in Feeding Extremely Premature Infants.” Breastfeeding Medicine. February 2012; 7(1):29-37 | doi: 10.1089/bfm.2011.0002.
  5. Bisquera JA, Cooper TR, Berseth CL. “Impact of Necrotizing Enterocolitis on Length of Stay and Hospital Charges in Very Low Birth Weight Infants.” Pediatrics. March 2002; 109(3):423-8 | doi:10.1542/peds.109.3.423.
  6. ABM Clincial Protocol #8: “Human Milk Storage for home use for full term infants”. Revision March 2010. Breastfeeding Medicine. Vol. 5, No. 3. 2010.
  7. Arnold LD. “The cost-effectiveness of using banked donor milk in the neonatal intensive care unit: prevention of necrotizing enterocolitis”. J Hum Lact 2002 May;18(2):172-7.

100% Human Milk Diet reduces the risk of Complications of Prematurity

  1. Hair A, et al. “Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk–Based Diet.” Breastfeeding Medicine. March 2016; 11(2): 70-74 | doi:10.1089/bfm.2015.0134.
  2. Herrmann K, Carroll K. “An Exclusively Human Milk Diet Reduces Necrotizing Enterocolitis.” Breastfeeding Medicine 1 May 2014; 9(4): 184-190 | doi:10.1089/bfm.2013.0121.
  3. Huston RK, Markell AM, McKulley EA, et al. “Decreasing Necrotizing Enterocolitis and Gastrointestinal Bleeding in the Neonatal Intensive Care Unit: The Role of Donor Human Milk and Exclusive Human Milk Diet in Infants Less <= to 1500 g birth weight.” ICAN: Adult Child and Adolescent Nutrition. 20 August 2013;|doi:10.1186/1471-2431-13-127
  4. Bell EF. “Preventing necrotizing enterocolitis: what works and how safe?” Pediatrics. January 2005; 115(1):173-4 | doi: 10.1542/peds.2004-2360
  5. Kosloske AM. “Breast Milk Decreases the Risk of Neonatal Necrotizing Enterocolitis.” Advances in Nutritional Research. 2001; 6: 123-137.
  6. Lucas A, Cole TJ. “Breast milk and neonatal necrotising enterocolitis.” Lancet. 1990 Dec 22-29;336(8730):1519-23.

Reduced Infections & Improved Immunity from 100% Human Milk Diet

  1. Hanson LA, Korotova M. “The role of breastfeeding in the prevention of neonatal infection.” Semin Neonatology.2002; 7: 275-281.
  2. El-Mohandes AE, Picard MB, Simmens SJ, et al. “Use of Human milk in intensive care nursery decreases the incidence of nosocomial sepsis.” J Perinatol. 1997; 17: 30-34.
  3. Cochi S, Fleming DW, Hightower AW, et al. “Primary invasive Haemophilus influenzae type b disease: a population-based assessment of risk factors.” J Pediatr.1986 Jun;108(6):887-96.
  4. Narayanan I, Prakash K, Gujral VV “The value of human milk in the prevention of infection in the high-risk low-birth-weight infant.” J Pediatr. 1981 Sep;99(3):496-8.
  5. Terpstra FG et al. “Antimicrobial and antiviral effect of high-temperature short-time (HTST) pasteurization applied to human milk”. Breastfeed Med. 2007 Mar;2(1):27-33.

Policies & Human Milk Banking

  1. Policy Statement from the American Academy of Pediatrics. “Breastfeeding and the Use of Human Milk.” Pediatrics. 2012 | doi: 10.1542/peds.2011-3552.
  2. Meier PP, Engstrom JL, Patel AL, et al.. “Improving the Use of Human Milk During and After the NICU Stay.” Clin Perinatol. March 2010; 37(1):217-45. | doi:10.1016/j.clp.2010.01.013.
  3. Breast Pumps. US FDA, Heal. Cent. “Devices Radiol. Center for Devices and Radiological Health”; 2013
  4. Janjindamai W, Thatrimontrichai A, Maneenil G, Puwanant M. “Soft Plastic Bag Instead of Hard Plastic Container for Long-term Storage of Breast Milk”. Indian J Pediatr 2013 Oct;80(10):809-13.
  5. National Institute for Health and Care Excellence. “Donor breast milk banks: the operation of donor milk bank services”. NICE clinical guideline 93.
  6. Thompson N, Pickler RH, Munro C, Shotwell J. “Contamination in expressed breast milk following breast cleansing”. J Hum Lact 1997 Jun;13(2):127-30.
  7. Arnold LD. “A brief look at drip milk and its relation to donor human milk banking”. J Hum Lact 1997 Dec;13(4):323-4.
  8. Prime DK, Garbin CP, Hartmann PE, Kent JC. “Simultaneous breast expression in breastfeeding women is more efficacious than sequential breast expression”. Breastfeed Med 2012 Dec;7(6):442-7.
  9. Morera PS, Castellote Bargallo AI, Lopez Sabater MC. “Evaluation by high-performance liquid chromatography of the hydrolysis of human milk triacylglycerides during storage at low temperatures”. J Chromatogr A 1998 Oct 9;823(1-2):467-74.
  10. CDC. “Proper Handling and Storage of Human Milk. Recommendations. Breastfeeding”.
  11. Simmer K, Hartmann B. “The known and unknowns of human milk banking”. Early Hum Dev 2009 Nov;85(11):701-4.
  12. Hartmann BT, Pang WW, Keil AD, Hartmann PE, Simmer K. “Best practice guidelines for the operation of a donor human milk bank in an Australian NICU”. Early Hum Dev 2007 Oct;83(10):667-73.