Sepsis is the commonest cause of death for new born babies worldwide. Mohan Pammi and Gautham Suresh from Baylor College of Medicine in Houston in the USA updated the Cochrane review of the evidence on the use of lactoferrin, in June 2017. Mohan describes the latest findings.
John: Hello, I'm John Hilton, editor of the Cochrane Editorial unit. Sepsis is the commonest cause of death for new born babies worldwide. Mohan Pammi and Gautham Suresh from Baylor College of Medicine in Houston in the USA updated the Cochrane review of the evidence on the use of lactoferrin, in June 2017. Mohan describes the latest findings.
Mohan: Lactoferrin is present in significant amounts in human colostrum, milk, tears, saliva and in neutrophilic granules. It has significant antimicrobial activity against organisms that cause neonatal sepsis. Lactoferrin enhances host defense against infections and modulates inflammation. Neonatal sepsis and necrotizing enterocolitis (NEC), are responsible for significant mortality and morbidity in preterm babies, even if they receive adequate antibiotic therapy. Therefore, newer strategies that are anti-inflammatory as well as antimicrobial may be beneficial. Lactoferrin might help with this and oral formulations of bovine and human lactoferrin are now widely available and generally regarded as safe.
We have updated the review of the evidence for the safety and effectiveness of lactoferrin supplementation to enteral feeds for the prevention of sepsis and NEC in preterm babies. We also reviewed the effects of lactoferrin on other important problems for preterm babies namely, duration of positive-pressure ventilation, development of chronic lung disease and length of hospital stay. We also wanted to look at periventricular leukomalacia and adverse neurological outcomes at two years of age or later, but there was no evidence on either of these in the studies we found.
There are six randomized trials now that are eligible for inclusion, published in eight reports, with three of these reporting one Italian multicenter trial. The other five trials are from the United States, Turkey, Canada, India and Peru.
The data from the six trials shows that enteral lactoferrin supplementation decreased late-onset sepsis (which is sepsis more than 72 hours after birth), NEC stage II or III but did not change "all-cause mortality". We graded this as low-quality evidence because of high risk of bias in the included studies and inconsistency of evidence.
In one study, which we judged to be of high risk of bias, adding lactoferrin to enteral feeds with probiotics decreased late-onset sepsis and NEC stage II or III but not "all-cause mortality".
Considering the other outcomes, lactoferrin supplementation to enteral feeds with or without probiotics decreased bacterial sepsis, fungal sepsis and urinary tract infections but not chronic lung disease, duration of mechanical ventilation or length of hospital stay. Investigators reported no adverse effects.
In summary, there is currently low-quality evidence that lactoferrin supplementation to enteral feeds with or without probiotics, decreases late-onset sepsis and NEC stage II or III in preterm babies, without causing adverse effects. However, better evidence should come after completion of ongoing trials that would add up to 6000 preterm babies randomized to lactoferrin. Research is also needed to clarify optimal dosing regimens for lactoferrin, type of lactoferrin (human or bovine) to be used, and information on long-term outcomes.
John: To read more about the current evidence and to watch for future updates of the review as the additional evidence becomes available, go online to Cochrane Library dot com and search 'lactoferrin and preterm infants'.