BackgroundThe inhibition of gastric acid secretion with ranitidine is frequently prescribed off-label to newborns admitted to neonatal intensive care units (NICU). Some studies show that the use of inhibitors of gastric acid secretion (IGAS) may predispose to infections and necrotising enterocolitis (NEC), but there are few data to confirm this association. This study aimed to compare the rates of neonatal infections and NEC among preterm infants (<37 weeks gestation) hospitalised in a NICU exposed or not to treatment with ranitidine.MethodsA retrospective cohort study was conducted with all consecutive preterm newborns admitted to a NICU between August-2014 and October-2015. The rates of infection, NEC, and death of newborns exposed or not to ranitidine were recorded.ResultsA total of 300 newborns were enrolled, of which 115 had received ranitidine and 185 had not. The two groups were similar with regard to the main demographic and clinical characteristics. Forty-eight (41.7%) of the 115 infants exposed to ranitidine and 49 (26.5%) of the 185 infants not exposed were infected (RR = 1.6, 95%CI 1.1–2.2, p = 0.006). The late onset (>48 h) blood culture positive infection rate was higher in the group exposed to ranitidine than in the untreated group (13.0% vs. 3.8%, p = 0.001). There was no significant association between the use of ranitidine and NEC (Bell stage >II) (p = 0.36). The mortality rate risk was 4-fold higher in infants receiving ranitidine (16.5% vs. 8.6%, p < 0.001).ConclusionRanitidine use in neonates was associated with an increased risk of infections and mortality, but not with NEC.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-017-2482-x) contains supplementary material, which is available to authorized users.

Background The use of histamine-2 receptor antagonists (H 2 RA) in neonates is still debated because of possible risk of infection, necrotizing enterocolitis (NEC) and increased mortality. Aim To review whether the use of H 2 RA in neonates admitted to neonatal intensive care units (NICU) is associated with infection, NEC or mortality. Materials and method We performed a systematic search in PubMed, Web of Science and SCOPUS databases using the terms “histamine-2 receptor antagonists”, “infection”, “necrotizing enterocolitis”, “mortality”, “neonates” and related terms to identify studies published up to April 30, 2017. We included studies conducted in hospitalized neonates and exposed to H 2 RA. The primary outcomes were infection, NEC and mortality. We included reports of infections with clinical signs and positive culture, and NEC according to Bell stages (stage ≥II) based on standardised clinical and radiologic criteria. Among 1,144 studies identified, 10 fulfilled the selection criteria. Information extracted included study design, sample size and number of participants, along with the outcomes of interest. We conducted a meta-analysis of adjusted data and pooled estimates of infection, NEC and mortality are reported as odds ratios (OR) and 95% confidence intervals (95%CI). Results Ten studies were analysed. There were substantial associations between H 2 RA and infection (pooled OR: 2.09; 95%CI: 1.35–3.24; P = 0.001) and NEC (pooled OR: 2.81, 95%CI: 1.19–6.64; P = 0.02) but not with the mortality risk (pooled OR: 1.76; 95%CI: 0.50–6.16; P: 0.38). Conclusion Current evidence suggests that H 2 RA is associated with an increased risk of infection and NEC, but not with mortality in neonates admitted to NICU. The use of H 2 RA in neonates must be stringently considered when necessary.