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A randomized, controlled study of prophylactic ranitidine in preventing stress-induced gastric mucosal lesions in
A L Kuusela1, T Ruuska, R Karikoski
1Medical School, University of Tampere, Finland.
Insights
Short-term ranitidine effectively prevents stress-induced gastric lesions in critically ill newborns. This prophylactic treatment significantly reduced mucosal damage and ulcers in neonatal intensive care unit patients without reported side effects.
Area of Science:
- Neonatal Medicine
- Gastroenterology
- Pharmacology
Background:
- Neonatal intensive care unit (ICU) patients are at high risk for stress-induced gastric mucosal lesions.
- Early diagnosis and prevention of these lesions are crucial for infant outcomes.
Purpose of the Study:
- To evaluate the efficacy of short-term prophylactic ranitidine treatment in preventing gastric lesions in mechanically ventilated neonatal ICU infants.
Main Methods:
- Prospective, randomized, controlled study involving 53 infants.
- Ranitidine administered prophylactically for 4 days to infants requiring mechanical ventilation.
- Endoscopic and histological evaluation of gastric mucosa at 3-6 days, alongside outcome registration.
Main Results:
- Ranitidine significantly reduced visually assessed gastric mucosal lesions (61% normal vs. 20% in controls, p < .004).
- Histological evaluation showed parallel results (57% vs. 16%, p < .004), with no ulcers in the ranitidine group.
- Prophylactic ranitidine decreased the risk for gastric mucosal lesions by 0.03 (95% CI 0.003-0.178).
Conclusions:
- Short-term prophylactic ranitidine is effective in preventing gastric mucosal lesions in stressed newborn infants.
- No adverse side effects were attributed to ranitidine treatment.
- Surfactant treatment for respiratory distress syndrome also showed a protective effect.
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.