Efficacy and Safety of Caffeine for Preterm Infants with Apnea at Less than 28 Weeks of Gestational Age

Abstract

Although the package insert of Respia^® injection or oral solution (a caffeine preparation) states, “Efficacy and safety for preterm infants with a gestational age of < 28 weeks (at the time of administration) have not been established,” our previous study found that caffeine was also used for such preterm infants. We therefore examined the efficacy and safety of caffeine for preterm infants of < 28 weeks of gestational age in comparison to those of ≥ 28 weeks of gestational age. The rate of improvement in apnea attacks from days 1 to 10 was significantly higher in the ≥ 28 weeks group. From day 3 onward, the percentage of cases that showed “improvement” did not differ to a significant extent, with the exception of day 6. Adverse events occurred in 100％ of the patients in the < 28 weeks group and 84.8％ of the patients in the ≥ 28 weeks group; however, the difference was not statistically significant. In addition, there was no significant difference between the two groups in the incidence of adverse events that were suspected of having been caused by caffeine. These results suggest that although the effects took slightly longer to occur in the preterm infants of < 28 weeks of gestational age at the start of administration, the efficacy and safety of caffeine treatment in preterm infants of < 28 weeks of gestational age were generally similar to the efficacy and safety in those of ≥ 28 weeks of gestational age.