STUDY OF COMPARATIVE EFFICACY AND ADVERSE EFFECTS OF CAFFEINE AND AMINOPHYLLINE IN THE MANAGEMENT OF APNEA OF PREMATURITY: A RANDOMIZED CONTROL TRIAL
Journal of Evolution of Medical and Dental Sciences
Apnea of prematurity (AOP) is one of the most common respiratory disorder in the NICU. Methylxanthine derivatives have been administered to decrease the frequency of apneic episodes and prevent the need for assisted ventilation. AIMS: To compare the efficacy and adverse effects of caffeine and aminophylline in the management of AOP. Settings & design: It is a non-inferiority, randomized control trial in the NICU of tertiary care hospital. MATERIAL & METHODS: All intramural preterm neonates
... osed as having AOP and satisfying the predefined inclusion criteria were randomized to receive either intravenous caffeine (n=20) or intravenous aminophylline (n=20) as per standard dosage and schedule. Neonates whose apnea episodes were not controlled by the assigned drugs were subsequently subjected to CPAP/mechanical ventilation. Apnea frequency was calculated to assess and compare efficacy of the either drug. Requirement and response to CPAP/mechanical ventilation was observed and adverse reactions to the either drug noted in each case. Statistical analysis: It was carried out by chi-square test & independent t-test. P value <0.05 was considered significant. RESULTS: A >50% reduction in apnea frequency was observed with the use of caffeine or aminophylline at the end of Day 5 of management. There was no significant difference (P >0.05) in the apnea frequency between the two groups on days 0, 1 and 5. Requirement and response of CPAP/mechanical ventilation was similar (P>0.05) with the use of either drug. Adverse effects like feeding intolerance and vomiting were more frequently associated with aminophylline as compared to caffeine. CONCLUSION: Intravenous caffeine was as efficacious as intravenous aminophylline in management of AOP and associated with relatively less adverse effects.