Therapeutic drug monitoring-guided individualized caffeine dosing for apnea of prematurity: Clinical efficacy and association with early neurobehavioral outcomes in preterm infants

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Abstract: Background: Given the high incidence of apnea of prematurity (AOP) and the repeated hypoxia-induced nerve damage, treatment optimization from the dosing perspective is critical. Caffeine is the current first-line therapeutic drug for AOP. However, the conventional dose results in low blood concentration compliance, with significant variation among individuals. Objectives: To explore the clinical efficacy and safety of a therapeutic drug monitoring (TDM)-guided individualized caffeine dosage regimen and its association with early neurobehavioral development and weight gain in preterm infants (PTIs). Methods: In this retrospective propensity score-matched cohort study, 130 PTIs with AOP were included after 1:1 matching, with 65 infants in the TDM-guided individualized dosing group and 65 in the conventional fixed-dose group. Inter-group comparative assessments were conducted from the perspectives of blood drug concentration compliance rates, apnea control, adverse reactions, neurobehavioral development scores, clinical outcomes and weight gain rates. Results: Compared with the conventional fixed-dose group, the TDM-guided individualized dosing group had a significantly higher target attainment rate of blood caffeine concentration (92.31% vs 70.77%; OR=5.22, 95% CI 1.68-12.74, P=0.002), lower apnea episode frequency at 4 weeks (MD -1.40 times/day, 95% CI -2.13 to -0.67, P