Use of ranitidine is associated with infections in newborns hospitalized in a neonatal intensive care unit: a cohort study

Abstract

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.

Use of pH reagent strips to verify gastric tube placement in newborns

“…Another factor that may influence the pH of gastric secretion is the use of histamine H 2 receptor antagonist drug. Although its use is associated with an increased risk of infections and necrotizing enterocolitis, this drug is often used in neonatal care for stress ulcer prophylaxis and in the treatment of gastroesophageal reflux disease ( 24 - 25 ) .…”

Preadmission Diet and Zip Code Influences the Pediatric Critical Care Clinical Course for Infants with Severe Respiratory Illness (N = 187)

“…31 In our population irrespective of diet or steroid use, ranitidine was prescribed in 37/39 (95%) of ventilated patients. Its use has recently been reported in the neonatal population and associated with a predisposition to necrotizing enterocolitis 32 ; the subject warrants further exploration.…”

Antacid therapy for gastroesophageal reflux in preterm infants: a systematic review

“…Another recent retrospective cohort study showed that ranitidine use was associated with an increased risk of infections and mortality in preterm infants, but not with NEC. 17 Wheatley and Kennedy showed that ranitidine did not reduce, and may have increased, bradycardia episodes in preterm infants with bradycardia attributed to GOR. 10 Wheatley and Kennedy compared the combination of two interventions together against a placebo, ranitidine, a H2 RA and metoclopramide, a dopamine receptor antagonist.…”