This should be characterized as a pilot trial, as there were only 60 patients per group, and as a trial of prophylaxis against infections, you need many more than that to have adequate power (which is stated by the authors). The study was otherwise of high quality, and was the first clinical trial of this agent in human babies, so a pilot trial is quite appropriate. They used human recombinant lactoferrin, called talactoferrin, tLF (apparently manufactured by some helpful fungi), to try and prevent infections; enrolled babies received it on days 1 through 28 of life, the tLF dose was 150 mg/kg every 12 hours. Eligible babies were between 750 and 1500 grams birth weight. Basically tLF was safe, there were no adverse events related to the protein recorded. The rate of significant infections was 17% in the tLF group, and 33% in the controls. The rate of blood culture positive sepsis was 10% compared to 17%. These differences could be due to chance, in a study of this size, but they are suggestive of a possible real effect.
Sherman MP, et al. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. The Journal of pediatrics. 2016;173, Supplement:S37-S42. This sub-study included 21 of the babies in the trial, and only in 2 NICUs not 3 as in the original trial. Stool was collected on day 21 and the microbiome analyzed using molecular techniques. There were differences between tLF and control babies, and also differences between the 2 hospitals. In NICU 2 the antibiotics in this group of babies were used for twice as long, and TPN continued for twice as long; NICU 2’s babies had much lower bacterial density than the other hospital. In addition, “tLF prophylaxis reduced the fecal composition of staphylococci to nearly undetectable levels. A reduction in staphylococci in the bloodstream and central-line infections in our VLBW infants was associated with this finding”.
This adds to the data supporting further large trials of lactoferrin, both talactoferrin and bovine lactoferrrin warrant investigation. A head to head trial afterward is probably too much to hope for, but, as tLF is likely to be immensely more expensive than bLF, it would be important to prove it more effective in order to buy it.