Abstract

Study objectives: To determine the safety and efficacy of the use of oral anhydrous caffeine and intravenous aminophylline in the neonatal population using therapeutic drug levels and clinical effects as markers for determination.Design: Prospective randomised study.Patients: Thirty-one neonates admitted (aminophylline n = 16, caffeine n = 15) with a gestational age of less than or equal to 34 weeks for prevention of apnoea of prematurity (AOP) were enrolled.Results: Oral anhydrous caffeine or intravenous aminophylline were administered using prescribed study regimens. One peak level was taken for the two drugs on day 4 of treatment 2 hours after the maintenance dose was administered. The two regimens were clinically monitored using cardiovascular, respiratory, gastro-intestinal and central nervous system parameters four hourly. The two groups did not differ significantly for gestational age (p = 0.782), birth weight (p = 1), gender (p = 0.722), and Apgar scores determined at 5 minutes (p = 0.068). Serum concentrations were within range (5–20 μg/ml) for both study groups. The median pulse rate (beats per minute) for two days; day 7: 160 vs. 148 (p = 0.019); day 9: 168 vs. 147 (p = 0.020) and median respiratory rate (breaths per minute) for five days; day 3: 68 vs. 61 (p = 0.039); day 4: 67 vs. 57 (p = 0.014); day 5: 64 vs. 58 (p = 0.045); day 7: 65 vs. 50 (p = 0.021); day 8: 66 vs. 56 p = 0.014) were significantly higher in the aminophylline study arm.Conclusion: The findings of the study indicated that caffeine is an effective alternative for intravenous aminophylline in prevention of AOP. The oral administration of caffeine may also have an advantage in a resource-poor setting.

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