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Probiotics reduced stage II or greater NEC in very preterm infants
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The use of certain probiotics reduced the incidence of necrotizing enterocolitis among preterm infants, according to new study findings.
Rates of Bell stage II or greater of necrotizing enterocolitis (NEC) was significantly lower in very preterm infants who received a combination of Bifidobacterium infantis, Streptococcus thermophilusandB. lactis compared with infants who did not receive probiotics. However, probiotics did not affect rates of late-onset sepsis or mortality, according to study results published in Pediatrics.
Susan E. Jacobs, MD, of The Royal Women’s Hospital in Melbourne, Australia, and colleagues examined 1,099 very preterm infants between October 2007 and November 2011 to determine the effect of administering a specific combination of probiotics on culture-proven late-onset sepsis.
Patients weighing less than 1,500 g and born before 32 completed weeks’ gestation were randomly assigned to B. infantis, S. thermophilusand B. lactis (n=548) or placebo (551).
Among controls, rates of definite late-onset sepsis (16.2%), NEC of Bell stage II or more (4.4%), and mortality (5.1%) were low, whereas breast-feeding rates were high (96.9%).
Significant differences were not found between definite late-onset sepsis or all-cause mortality. However, the combination probiotic reduced NEC of Bell stage II or more (RR=0.46; 95% CI, 0.23-0.93).
“Although this probiotic combination did not affect all-cause mortality, it appears to be safe, cheap, and readily implemented,” the researchers wrote. “These results may assist neonatal units considering using probiotics for very preterm infants. Probiotics may be of greatest value globally in neonatal settings with high rates of NEC, mortality, and late-onset sepsis.”
For more information:
Bell MJ. Ann Surg. 1978;187:1-7.
Jacobs SE. Pediatrics. 2013;doi:10.1542/peds.2013-1339.
Disclosure: Solgar supplied the probiotic combination “ABD Dophilus Powder for Infants” at cost. The study was funded in part by the National Health and Medical Research Council of Australia, The Royal Women’s Hospital Foundation and the Angior Family Foundation.
Perspective
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David A. Kaufman, MD
The role of probiotics in preventing infection and NEC continues to be debated. Which probiotics, how many probiotics, what dose and duration, and who benefits remain critical questions. In this study by Jacobs et al., infants younger than 32 weeks and less than 1,500 g were randomized and received probiotics or placebo until discharge or 40 weeks corrected age. They report in an RCT of 1,100 preterm infants, that the probiotic combination of Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis did not reduce the primary outcome of late-onset infection, but did reduce NEC (≥Stage II) from 4.4% to 2.0%. Overall mortality and infection-related mortality was similar in both groups. The study was slightly weighted to more mature infants with 60% being 28 weeks or older and 40% were younger than 28 weeks gestation. The combination of probiotics was selected as it was the only probiotic combination available at the time that had been previously evaluated in preterm infants.Interestingly, the effect of probiotics decreased late-onset sepsis in infants 28 weeks or older (10.8 to 5.5%; P=0.01), but did not have an effect for infants younger than 28 weeks (24.7% vs 23.4%). The same pattern was seen with NEC. The effect of probiotics was decreased in infants 28 weeks or older (2.2 to 0%; P=0.02), but did not have an effect for infants younger than 28 weeks (7.2% to 2%).
So, this study continues to move the evidence forward and also generates new questions. With this combination of probiotics, is the effect on infections and NEC only in infants 28 to 31 weeks? Randomization of infants to less than 32 weeks and less than 1,500 g selects for SGA infants in the 28 to 31 week patients, so is this benefit more for SGA infants? Can it be recommended for infants younger than 28 weeks gestation? It is difficult to discern if many infants at 24 weeks or younger were in the study. What if a NICU doesn’t have these probiotics available, what other probiotics work? This study had high breastfeeding rates, so is the effect greater if an infant is receiving formula or does it have different effects for breastfeed compared to formula feed preterm infants? The authors leave us with other questions. They did a study but they conclude the greatest value would be in setting with high rates, but this study did not test that question. Probiotics definitely have a role in the NICU, but in combination with other key variables such as breastfeeding and gestational age, plus product availability, further study is still needed for certain patients.
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