The latest systematic review of Probiotics to Prevent NEC in Preterm infants Wang Q, Dong J, Zhu Y: Probiotic supplement reduces risk of necrotizing enterocolitis and mortality in preterm very low-birth-weight infants: an updated meta-analysis of 20 randomized, controlled trials. J Pediatr Surg 2012, 47(1):241-248. http://www.sciencedirect.com/science/article/pii/S0022346811008360
With the addition of 4 studies in the Chinese literature this review which now includes over 4000 babies confirms a reduction in NEC, by 67%, and a reduction in mortality of 44%. Unfortunately there was no further data regarding mortality added by the Chinese trials.
At the recent Pediatric Academic Societies meeting in Boston 2012, the results of another trial were presented (Rojas M and Lozano J). Mario Rojas and the Columbian Neonatal research Collaborative have done a number of very nice trials; this one in relatively low risk babies, showed less NEC and fewer deaths. Their primary outcome was mortality and nosocomial infection, which was not statistically significantly affected by probiotics.
Just as I was about to ‘go live’ with this blog, yet another trial has been published, this small trial had 75 infants per group of less than 1500 g birth weight. They had fewer cases of NEC and fewer deaths with a probiotic mixture compared to the controls.
Fernández-Carrocera LA, Solis-Herrera A, Cabanillas-Ayón M, Gallardo-Sarmiento RB, García-Pérez CS, Montaño-Rodríguez R, Echániz-Aviles MOL: Double-blind, randomised clinical assay to evaluate the efficacy of probiotics in preterm newborns weighing less than 1500 g in the prevention of necrotising enterocolitis. Archives of Disease in Childhood – Fetal and Neonatal Edition 2012. http://fn.bmj.com/content/early/2012/05/03/archdischild-2011-300435.full
So I just did an update of the meta-analysis, taking out Paolo Manzoni’s important Lactoferrin trial, as there were 3 groups and it’s too complicated to think about what to do with those data when I am on call. I also took out the Costalos study as it was a Saccharomyces, that is a probiotic fungus, and clearly different to the other studies. As you can see the RR for NEC is 0.41 with very tight confidence intervals. Similarly there is a reduction in death of 42%, with a 95% confidence of the true reduction in death being between 56% and 25%.
There are no reported adverse events in any of the studies.
What more will it take to make this routine therapy in at-risk infants?