A RANDOMIZED, CONTROLLED-STUDY OF PROPHYLACTIC RANITIDINE IN PREVENTING STRESS-INDUCED GASTRIC-MUCOSAL LESIONS IN NEONATAL INTENSIVE-CARE UNIT PATIENTS

Objective: To assess endoscopically the effect of prophylactic short-t erm ranitidine treatment in the prevention of stress-induced gastric l esions in neonatal intensive care unit (ICU) patients. Design: Prospec tive, randomized study. Setting: Department of Neonatal Intensive Care , University Hospital of Tampere. Patients: Fifty-three infants were e nrolled in a randomized, controlled study. Forty-eight (90%) of these patients underwent endoscopic examination and were evaluated. Interven tions: A histamine-2-receptor blocker, ranitidine, was given prophylac tically after birth for 4 days to infants mechanically ventilated and treated in the neonatal ICU. The gastric mucosa was both visually and histologically evaluated after 3 to 6 days, and the outcome of the inf ants was registered. Measurements and Main Results: In the 23 infants prophylactically treated with ranitidine, the gastric mucosa was visua lly classified as normal in 14 (61%) infants as compared with five (20 %) of 25 controls (p<.004). Histologic lesions showed parallel results (57% vs. 16%, p <.004). Eight gastric ulcers were diagnosed endoscopi cally in the control group vs. none in the treatment group. The ulcers were all clinically ''silent'' at the time of endoscopy. According to logistic regression modeling, the decreased risk for gastric mucosal lesions in infants receiving prophylactic ranitidine was 0.03 (95% con fidence interval 0.003 to 0.178). Surfactant treatment for infant resp iratory distress syndrome also decreased the risk for stress-induced g astric mucosal lesions (odds ratio 0.083; 95% confidence interval 0.00 9 to 0.788), whereas other variables (birth weight, gestational age, A pgar scores, cord blood pH, and duration of intubation) had no signifi cant effect. No side effects could be attributed to the ranitidine tre atment. Conclusion: We conclude that short-term prophylactic ranitidin e treatment prevents gastric mucosal lesions in newborn infants under stress.