In a retrospective cohort sequential analysis, medical records for 311 premature infants were reviewed, 232 in the years before introduction of Lactobacillus reuteri Protectis prophylaxis (January 2004 – June 2009) and 79 who received Lactobacillus reuteri Protectis prophylaxis (June 2009 – April 2011).
The review compared the rates of NEC in premature infants ≤ 1000 grams birth weight. The incidence of NEC was significantly lower in the infants who received Lactobacillus reuteri Protectis, 2 of 79 infants (2.5%) compared to 35 of 232 (15.1%) of the untreated infants (p=0.0475). Rates of late-onset gram-negative or fungal infections were not significantly different between the treated and untreated group, 22.8 versus 31%.
No adverse events related to the use of Lactobacillus reuteri Protectis were noted. The preventive supplementation of Lactobacillus reuteri Protectis resulted in avoidance of one case of NEC for every eight infants treated (NNT=8).
NEC associated with only medical treatment occurred in 6.9% infants before the introduction of prevention and none after routine Lactobacillus reuteri Protectis prophylaxis, a significant reduction (=0.0143). The combined effect of surgical NEC and fatal NEC (which are surgical cases) were reduced from 8.2 to 2.5%, a non significant difference (p=0.1774)
Prophylactic supplementation of Lactobacillus reuteri Protectis as prevention of NEC resulted in a statistically significant reduction in NEC, from 15.1% to 2.5%. This corresponds to one avoided case of NEC for every eight infants treated. The benefits were especially focused on the subsets of medical NEC and death related to NEC.