Читать книгу Human Milk: Composition, Clinical Benefits and Future Opportunities - Группа авторов - Страница 19

There are 3 categories of randomized controlled trials (RCTs) that provide evidence on the benefits of HM or adverse impact of CM.

1. Historical trials [18] comparing EHM feeding versus CM-based products (used either alone or in combination with HM). In these trials, the HM arm received no CM since this was the era before the development (in the later 1980s) of CM-based breast milk fortifiers. The largest of such trials was by Lucas et al. on over 500 infants but at least 5 other smaller RCTs of this nature were done by other investigators.

2. The historic fortifier trial of Lucas et al. [19] tested the clinical impact of adding CM-based fortifier to breast milk versus no fortification (which was ethical at this time when fortifiers were just being introduced into practice).

3. A third RCT category has a long history, as explained here. In the late 1970s, the first evidence began to emerge that HM protected against necrotizing enterocolitis (NEC) and sepsis. However, extensive research showed that HM alone did not meet the needs of preterm infants for protein and other nutrients needed to fuel the rapid growth of the preterm infant, notably the growth and development of the brain. In response to this, CM-based special preterm infant formulas were devised in the 1970s (CM-based HM fortifiers came later in the 1980s) – but by the late 1970s evidence began to accumulate that CM products had adverse effects. In response to this, Lucas et al. [20] developed the concept of lacto-engineering whereby donor breast milk (DBM) was separated and reconstituted to produce HM-based formulations enriched in HM protein and fat that met nutritional needs of preterm infants and allowed total exclusion of CM. The HIV epidemic in the 1980s closed down HM banks, but with the more recent re-emergence of milk banking the opportunity arose for commercial production of HM-based fortifiers and preterm formulas allowing preterm infants to receive an exclusive HM (EHM)-based diet. In the USA, many level 3 or 4 neonatal intensive care units have used these HM-based products providing a new opportunity to do RCTs and quasi experimental studies comparing current practice using diets containing CM versus feeding an EHM diet with these modern lacto-engineered products.