Incorporating probiotics into the standard of care for preterm infants of less than 32 weeks' gestation may help significantly reduce the incidence of necrotizing enterocolitis (NEC), according to an article published online January 9 in the Journal of Pediatrics.
Annie Janvier, MD, from the Sainte Justine University Health Center, Montreal, Quebec, Canada, and colleagues compared outcomes for 294 infants in the Sainte Justine neonatal intensive care unit (NICU) who received probiotics during a 17-month study period, starting in August 2011, with outcomes for 317 infants admitted to the NICU from January through May 2011, before the regular use of probiotics. The NICU began administering a probiotics mixture to all admitted infants younger than 32 weeks' gestation after July 2011.
The researchers observed a significant ~50% decrease in the incidence of NEC from 9.8% during the earlier period to 5.4% during the probiotics period (P < .02), as well as a nonsignificant difference in deaths (9.8% to 6.8%; P >.05) and a significant difference in combined outcome of death or NEC (17% to 10.5%; P < .05). The improvements remained significant after adjusting for gestational age, intrauterine growth restriction, and sex.
"Easily Available" Product
Although the study was not a randomized controlled trial (RCT), the "study is from a large academic North American NICU, showing that the results in RCTs are indeed translatable to our environment," the researchers write. They point out that systematic reviews of more than 22 RCTs have documented reductions in NEC and death through routine use of probiotics in high-risk preterm infants.
The clinicians in this trial administered 0.5 g of a mixture of 4 Bifidobacteria (B breve, B bifidum, B infantis, and B longum) and Lactobacillus rhamnosus GG per day, starting with the first feed after admission and going until the infants were 34 weeks' postmenstrual age. The average duration of therapy was 24 days.
The authors used a commercially available formula (FloraBABY, Renew Life Canada), which has a Health Canada Natural Products number. The cost of the probiotic mixture averaged $2.51 (11 cents per day × 23.6 days). The researchers estimate that the cost per NEC or death saved was ~$50 (number needed to treat, 20).
They also observed a reduction in the duration of intravenous nutrition in the probiotics group and note that "the reduced cost of intravenous nutrition could easily exceed the costs of the probiotics."
They note that about 250 cases of NEC occur among 4000 "very preterm" infants each year in Canada, and they estimate that 4800 cases occur among 80,000 "very preterm" infants each year in the United States.
"This would imply that universal adoption of probiotic prophylaxis has the potential to prevent 2500 cases of NEC every year in North American neonatal units," they write.
"Probiotics should be considered standard of care and used routinely to all preterm infants of <32 weeks' gestation. Additional studies comparing strains and examining additional NICU populations and length of therapy are needed. There seems to be no further research to delay the introduction of this evidence-based therapy in the NICU," the authors conclude.
"Best Studied, Least Used"
"Probiotic supplementation in preterm infants is perhaps the best studied yet least used therapy in neonatal medicine," write William Tarnow-Mordi, MBChB, DCH, FRCPCH, from the Winner Centre for Newborn Research, University of Sydney, New South Wales, Australia, and Roger F. Soll, MD, from the Department of Neonatology, University of Vermont, Burlington, in an accompanying editorial published online February 10.
They suggest that clinicians may want to establish protocols for using probiotics, supported by local microbiologists, institutional review boards, and parent representative groups, and that probiotics should be manufactured under Good Manufacturing Practice.
"[I]f the results of research are to be implemented in a timely fashion with, rather than simply for the community, it will be important to seek the perspectives of parent representative groups," they write, "after openly sharing the pros and cons."
Asked why probiotics have not been universally adopted in North America, senior author Keith J. Barrington, MBChB, from Sainte Justine, told Medscape Medical News, "I am not sure about this. I have not understood the reluctance. On the other hand, there is no form of probiotics that is licensed for use in preterm infants for the prevention of NEC. That is not really an obstacle to use, as most of what we give in the NICU is not licensed specifically for the newborn, anyway. There have also been some prominent neonatologists who have been very negative about their introduction."
He agrees with the editorialist about involving parent groups. "I think parent groups might have great influence. On a wider level, I think we should have more interaction with and input from parent groups, [on] what is, for example, the 'standard of care.' If we can get parent groups to pressure NICU docs to give their babies probiotics, then there might be a faster adoption."
The authors and editorialists have disclosed no relevant financial relationships.
J Pediatrics. Published online January 9, 2014, and February 10, 2014. Article abstract, Editorial extract
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Cite this: NICU: Probiotics Reduce NEC, Should Be Routine, Experts Say - Medscape - Feb 19, 2014.