Summary of a clinical trial comparing breast milk fortifiers

Growth and nutritional biomarkers of preterm infants fed a new powdered human milk fortifier: a randomized trial.

Rigo, J. et al. (2017). Journal of Pediatric Gastroenterology and Nutrition.

About the paper

  • Published in the Journal of Pediatric Gastroenterology and Nutrition 2017.



  • The study evaluated growth and nutritional biomarkers of preterm infants fed breast milk supplemented with a new powdered breast milk fortifier (nBMF) or a control breast milk fortifier (cBMF). The nBMF provides similar energy content, 16% more protein (partially hydrolysed whey), and higher micronutrient levels than the cBMF, along with medium-chain triglycerides (MCTs) and docosahexaenoic acid (DHA). The nBMF is the same formulation as SMA ® PRO Breast Milk Fortifier.
  • The primary outcome was to assess weight gain velocity (g/day).
  • Secondary outcomes included: additional growth parameters, feeding tolerance, adverse events, time to full fortification/ full enteral feeding, markers of protein-energy, electrolytes, bone metabolic status, gut inflammation and maturity of gastrointestinal (GI) functions.


Why it’s important

  • Feeding breast milk rather than preterm formula provides many benefits to preterm infants, such as accelerated gut maturation, protection against infections and possible positive effect on neurodevelopment that are mediated by protective biomolecules and tropic factors in breast milk. However, preterm breast milk provides inadequate protein and micronutrients to support the rapid growth and bone mineralization of preterm infants.
  • ESPGHAN 2010 recommended fortification of breast milk for all preterm infants with birthweight <1800g to improve nutrient accretion and in-hospital growth 1,2.
  • Feeding fortified breast milk may help support adequate growth and bone mineralisation and is associated with favourable neurodevelopmental outcomes 3,4.



  • A controlled, multicentre, double-blind, randomised study.
  • Clinically stable preterm infants ≤32 weeks or ≤1500g were randomized to receive either the nBMF (n=77) or the cBMF (n=76) for a minimum of 21 days.
  • Weight gain was evaluated and nutritional status and gut inflammation were assessed. Adverse events were monitored.



  • Weight gain and rate of weight gain were higher in the group fed nBMF compared to the group fed cBMF. Length and head circumference gains were not different between the two groups.
  • The group fed nBMF had higher serum blood urea nitrogen, pre-albumin, alkaline phosphatase and calcium compared to the group fed cBMF.
  • Both breast milk fortifiers were well tolerated with similar incidence of gastrointestinal adverse events.


In summary, the nBMF is the same formulation as SMA ® PRO Breast Milk Fortifier. The results found that the formulation provided more protein and fat compared to the cBMF. Furthermore it was found to be safe, well-tolerated and to significantly improve the weight gain of preterm infants. The results of this study support the use of SMA ® PRO Breast Milk Fortifier with preterm infants .


To find out more about how SMA ® PRO Breast Milk Fortifier can be used with preterm infants, please click here


  1. Garcia, C. et al. (2013). Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand), 59(1), 108-131.
  2. Corpeleijn, W. et al. (2012). Intake of own mother's milk during the first days of life is associated with decreased morbidity and mortality in very low birth weight infants during the first 60 days of life. Neonatology,102(4), 276-281.
  3. Einloft, P. et al. (2015). Supplemented vs. unsupplemented human milk on bone mineralization in very low birth weight preterm infants: a randomized clinical trial. Osteoporos Int, 26(9), 2265-71.
  4. Gibertoni, al. (2015). Positive effect of human milk feeding during NICU hospitalization on 24 month neurodevelopment of very low birth weight infants: an Italian cohort study. PLoS ONE, 10(1), e0116552.

IMPORTANT NOTICE:  The World Health Organisation (WHO) has recommended that pregnant women and new mothers be informed on the benefits and superiority of breastfeeding – in particular the fact that it provides the best nutrition and protection from illness for babies. Mothers should be given guidance on the preparation for, and maintenance of, lactation, with special emphasis on the importance of a well-balanced diet both during pregnancy and after delivery. Unnecessary introduction of partial bottle-feeding or other foods and drinks should be discouraged since it will have a negative effect on breastfeeding. Similarly, mothers should be warned of the difficulty of reversing a decision not to breastfeed. Before advising a mother to use an infant formula, she should be advised of the social and financial implications of her decision: for example, if a baby is exclusively bottle-fed, more than one can (400 g) per week will be needed, so the family circumstances and costs should be kept in mind. Mothers should be reminded that breast milk is not only the best, but also the most economical food for babies. This product must be used under medical supervision. SMA® PRO Breast Milk Fortifier is a nutritional supplement designed to be added to expressed breast milk for the dietary management of feeding preterm low birthweight babies.