Informational for healthcare professionals
While the concept of human milk-based fortifiers is not new, there are only 3 companies in the world producing such fortifiers.
Our innovative technology allows us to produce unique products unmatched by our competitors.
The human alternative
To meet the specific nutritional needs of preterm neonates most clinicians and dieticians rely on cow milk-derived multinutrient fortifiers. While these have been used for decades and are generally viewed as safe, practices around their use vary widely and the evidence-base supporting their use is relatively weak.
While Human milk is the ideal nutrition for term infants, evidence indicates that the optimal development of preterm neonates require additional supplementation
| Recommended intake/kg/day(1, 2) |
Early preterm milk at 160 mL/kg/day |
Term milk (3) at 160mL/kg/day |
|
|---|---|---|---|
| Energy | 120 kcal | ~ 107 kcal | ~ 107 kcal |
| Protein | 3.5-4 (4.5) g | Typically below 2.6g | Invariably below 2.0 g |
| Calcium | 120 mg | ~ 50 mg | ~ 50 mg |
| Phosphorus | 60 mg | ~9 mg | ~ 9 mg |
Apart from macro and micronutrients, human milk also contains over 1000 bioactive components, many of which are not found in bovine or other animal milk. These include growth and development factors, components with immunologic protective roles, enzymes, transport proteins and other factors.
Extensive studies showed that, compared to cow milk-based formulas, human milk provided protection against common complications of prematurity. Some of these protective effects showed clear dose-dependence.
The practice of using ‘concentrates’ of human milk to support the development of preterm neonates started in the 1980s. Today almost 50% of NICUs in the US use human milk-derived fortifiers for this purpose
The literature on the benefits of HMDF use is extensive. They were shown to reduce length of stay, incidence of NEC, BPD, ROP and other complications, while reducing feed intolerance and cow’s milk protein intolerance/allergy. However, some of this work received industrial support, and systematic reviews question the superiority of HMDF over cow milk-derived fortifiers (CMDF)
(https://doi.org/10.1093/advance/nmaa039). Two independent RCTs by O’Connor (https://doi.org/10.1093/ajcn/nqy067) and more recently by Jensen et al also failed to find statistically significant benefits of HMDF fortification using their selected primary outcome measures. However, as highlighted by a recently published meta-analysis, the use of HMDF resulted in a ~50% reduction in mortality when independently conducted RCTs were analysed together (https://doi.org/10.3390/nu16060 10).
Fortifiers derived from human milk have been in use since the 1980s, and commercial products appeared on the US market in 2006. Latest data indicates that almost 50% of NICUs in the US use them. They are also widely used in Canada and India.
NICUs that use fortified milk use CMDF. However, the evidence base supporting this practice is poor
The latest systematic review by Bown et al. analyzed 18 RCTs on the use of cow milk-derived multinutrient fortifiers.
The data indicates that fortification increased weight gain by 1.76 g/day, while gains in length and head circumference were negligible. Generally, the RCTs were small and methodologically poor. The incidence of NEC was higher in the fortified group, although the difference did not reach statistical significance.
While the clinical evidence of EHMD is quite extensive
Using CDMF fortifier may lead to CMPA/CMPI
It is estimated that cow milk contains approximately 30 proteins that are known to can sensitize human infants.
The linked article provides an excellent review of these:
The clinical manifestations, pathophysiology, and potential management of CMPI is summarised in the linked article below:
