Comparative Study on Efficacy and Safety of Caffeine and Aminophylline for Apnea of Prematurity in Preterm (≤ 34 weeks)Neonates Admitted in a Tertiary Care Hospital
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background: Prematurity apnea is described as inability to breathe for 20 seconds or less, accompanied by bradycardia (Heart rate<100/ minute) or cyanosis, in neonates under 37 weeks' gestational age. Since the 1970s, methylxanthines have been used to treat apnea by stimulating breathing. Few developing country trials compare caffeine with aminophylline for efficacy and safety. To compare the effectiveness and the safety of Caffeine versus Aminophylline in the treatment of apnea of prematurity in Preterm Neonates (<34 weeks). Materials and methods: A prospective, open-label, randomized controlled trial was conducted from October 2022 to September 2023 in Ma-O-Sishu Hospital NICU. Neonates were randomly assigned to two therapy groups (Aminophylline and caffeine) based on their birth date (Odd or binary) given loading and maintenance doses, and documented for apnea, bradycardia, cyanosis, tachycardia, CPAP, mechanical ventilator. Results: The parental sociodemographic profile showed a mean paternal age of 35 years (SD ± 6.88) and maternal age of 28.2 years (SD ± 6.12). Most fathers were businessmen or working abroad (26.19% each) while mothers were primarily housewives (59.52%). The majority of families (76.19%) reported average socioeconomic status.Among 42 mothers, 85.71% had average nutrition and 95.24% received four antenatal visits. PROM was reported in 23.81%, UTI in 4.76%, and 57.14% had no sepsis risk. Co-morbidities included HTN (23.81%) GDM (19.05%) PET (11.90%) and hypothyroidism (9.52%) while 35.71% had none. In this study of 42 preterm neonates equally divided between aminophylline and caffeine groups (n=21 each) caffeine was significantly more effective in reducing daily apneic episodes (23.8% vs. 61.9%, χ² = 5.86, p = 0.016). The odds of frequent apnea were 5.2 times higher with aminophylline (95% CI: 1.3–21.0). Both groups were comparable in gestational age, birth weight, and apnea onset. Aminophylline treated neonates required longer maintenance dosing for sustained apnea-free periods (χ² = 25.6, p = 2.8×10-6 ) whereas caffeine-treated infants achieved apnea resolution with shorter CPAP support durations (χ² = 27.0, p = 1.4×10-6 ). These><34 weeks). Materials and methods: A prospective, open-label, randomized controlled trial was conducted from October 2022 to September 2023 in Ma-O-Sishu Hospital NICU. Neonates were randomly assigned to two therapy groups (Aminophylline and caffeine) based on their birth date (Odd or binary) given loading and maintenance doses, and documented for apnea, bradycardia, cyanosis, tachycardia, CPAP, mechanical ventilator. Results: The parental sociodemographic profile showed a mean paternal age of 35 years (SD ± 6.88) and maternal age of 28.2 years (SD ± 6.12). Most fathers were businessmen or working abroad (26.19% each) while mothers were primarily housewives (59.52%). The majority of families (76.19%) reported average socioeconomic status.Among 42 mothers, 85.71% had average nutrition and 95.24% received four antenatal visits. PROM was reported in 23.81%, UTI in 4.76%, and 57.14% had no sepsis risk. Co-morbidities included HTN (23.81%) GDM (19.05%) PET (11.90%) and hypothyroidism (9.52%) while 35.71% had none. In this study of 42 preterm neonates equally divided between aminophylline and caffeine groups (n=21 each) caffeine was significantly more effective in reducing daily apneic episodes (23.8% vs. 61.9%, χ² = 5.86, p = 0.016). The odds of frequent apnea were 5.2 times higher with aminophylline (95% CI: 1.3–21.0). Both groups were comparable in gestational age, birth weight, and apnea onset. Aminophylline treated neonates required longer maintenance dosing for sustained apnea-free periods (χ² = 25.6, p = 2.8×10-6 ) whereas caffeine-treated infants achieved apnea resolution with shorter CPAP support durations (χ² = 27.0, p = 1.4×10-6 ). These results suggest that caffeine is more effective than aminophyline in managing apnea in neonates. Conclusion: Caffeine decreases the need for CPAP and oxygen therapy. It is considered to have efficacy and safety outcomes in comparison with aminophyline. Chatt Maa Shi Hosp Med Coll J; Vol.25 (2); July 2026; Page 57-63
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7225233327