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A randomized, controlled study of prophylactic ranitidine in preventing stress-induced gastric mucosal lesions in neonatal intensive care unit patients

Kuusela, Anna-Leena MD; Ruuska, Tarja MD; Karikoski, Riitta MD; Laippala, Pekka PhD; Ikonen, R. Sami MD; Janas, Martti MD; Maki, Markku MD

Pediatric Critical Care

Objective  To assess endoscopically the effect of prophylactic short-term ranitidine treatment in the prevention of stress-induced gastric lesions in neonatal intensive care unit (ICU) patients.

Design  Prospective, randomized study.

Setting  Department of Neonatal Intensive Care, University Hospital of Tampere.

Patients  Fifty-three infants were enrolled in a randomized, controlled study. Forty-eight (90%) of these patients underwent endoscopic examination and were evaluated.

Interventions  A histamine-2-receptor blocker, ranitidine, was given prophylactically 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 infants was registered.

Measurements and Main Results  In the 23 infants prophylactically treated with ranitidine, the gastric mucosa was visually 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 endoscopically 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% confidence interval 0.003 to 0.178). Surfactant treatment for infant respiratory distress syndrome also decreased the risk for stress-induced gastric mucosal lesions (odds ratio 0.083; 95% confidence interval 0.009 to 0.788), whereas other variables (birth weight, gestational age, Apgar scores, cord blood pH, and duration of intubation) had no significant effect. No side effects could be attributed to the ranitidine treatment.

Conclusion  We conclude that short-term prophylactic ranitidine treatment prevents gastric mucosal lesions in newborn infants under stress. (Crit Care Med 1997; 25:346-351)

From the Medical School (Drs. Kuusela, Ruuska, and Maki) and Department of Public Health, Biometry Unit (Dr. Laippala), University of Tampere; Departments of Pediatrics (Dr. Kuusela, Ruuska, Ikonen, Janas, and Maki) and Pathology (Dr. Karikoski), Tampere University Hospital, Tampere, Finland.

Supported, in part, by a grant from the Finnish Foundation of Pediatric Research.

Address requests for reprints to: Anna-Leena Kuusela, MD, Department of Pediatrics, University of Tampere, Medical School, P.O.B. 607, FIN-33101 Tampere, Finland.

© Williams & Wilkins 1997. All Rights Reserved.