Clinical and biological impact of caffeine therapy in premature infants with apnea of prematurity: a prospective observational study.

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Background: Methylxanthines are the first-line medication in apnea of prematurity. However, serum concentrations exhibit marked variability due to immature hepatic metabolism and drug-drug interactions.Objectives: This study aimed to evaluate premature newborns diagnosed with apnea of prematurity and highlight the role of therapeutic drug monitoring in preventing complications related to overaccumulation.Methods: This prospective observational clinical study was conducted on 325 premature neonates, divided into high caffeine citrate study group with serum titer >50 μg/mL (HC, n = 25) and normal caffeine group with serum titer <50 μg/mL (NC, n = 50) and a comparison group that did not receive caffeine citrate (CoG, n = 250). CoG required pulmonary ventilation, while HC and NC received both pulmonary ventilation and standard caffeine citrate. Serum caffeine citrate concentrations were monitored dynamically.Results: Major complications in caffeine group were intracranial hemorrhage (5.33%) and convulsions followed by death (4.00%) as, while the CoG demonstrated fewer adverse outcomes and more favorable clinical evolution.Conclusion: Intermittent administration of standard methylxanthine doses or adjustment of therapeutic doses, guided by serial monitoring of serum caffeine citrate titer, may improve clinical outcomes in critical cases, reduce adverse drug effects, and support safer and individualized therapeutic management of apnea of prematurity.