Although this article carries important information to the
neonatal community, the cost-effectiveness results should be
interpreted with some caution. The results of our study are
based on the only randomized trial conducted so far comparing
bovine and donor HMFs. It could be possible that the
incidence of NEC and surgical NEC observed among the 12
NICU units (11 in the United States and one in Austria) in the
study of Sullivan et al.13 may or may not be representative of
the universe of NICU units catering to the healthcare needs
of EP infants. Given the lower frequencies of EP births and
NEC in the general population, the costs of conducting such
huge trials are prohibitive. Nevertheless, the primary driver
of costs savings is, in fact, the percentage reduction in rates of
overall NEC and surgical NEC in the HUM arm and not the
absolute NEC rates. The highly significant results obtained
for incidence of surgical NEC ( p¼0.007) would mean that
the results have less than 1 in 140 chance of being random.
Second, the use of statewide hospital discharge data to
evaluate the costs of NEC may be perceived as a potential
limitation of the study in that the feeding patterns among
infants in the discharge sample cannot be ascertained. At the
time the clinical trial started, however, Prolacta HMF was
not being used routinely in the United States; there were
perhaps fewer than 10 NICUs that were using Prolacta HMF
on a sporadic basis. Although real world data through chart
review may have provided better data on proportions of
milk use,