Prophylactic Aminophylline for Prevention of Apnea at Higher-Risk Preterm Neonates

Background: A few studies have been carried on preventive drugs for apnea of preterm neonates. Objectives: This study aimed to assess the safety and prophylactic effects of aminophylline on the incidence of apnea in premature neonates. Patients and Methods: This study was a randomized clinical trial (RCT) research. The prophylactic effect of aminophylline on apnea was investigated in premature babies in our NICU (IRAN-Isfahan). In the study group (A), 5 mg/kg aminophylline was initially administered as a loading dose. Then, every 8 hours, 1.5 mg/kg was given as maintenance dose for the next 10 days. In the control group (C), no aminophylline was used during the first ten days of life. Results: Fifty-two neonates were randomized for the study and all of them completed it. Primary outcomes were clearly different between the two groups. Only 2 infants (7.7%) who had been placed in aminophylline group developed apnea, as compared to 16 infants (61.5%) in the control group (P < 0.001). Three and four neonates (11.5%, 15.4%) in the aminophylline group developed bradycardia and cyanosis respectively, as compared to 16 infants (61.5%) who did not receive aminophylline (P < 0.001). Median time of need to NCPAP (Nasal Continuous Positive Airway Pressure) was 1 (0 - 4) days and 2.5 (0.5 - 6.5) days in group A and C, respectively (P = 0.03). No side effects were reported in neonates (P > 0.999). Median time of hospitalization was shorter in aminophylline group (P = 0.04). Conclusions: This study supports the preventative effects of aminophylline on apnea in extreme premature infants. In other words, the more premature an infant, the greater the preventative effect of aminophylline on the incidence of apnea and bradycardia.