Paediatr Drugs. 2025 Oct 14. doi: 10.1007/s40272-025-00723-4. Online ahead of print.
ABSTRACT
OBJECTIVE: Our objective was to describe the clinical impact of time to initiation of indomethacin or ibuprofen on patent ductus arteriosus (PDA) closure rates in preterm neonates.
METHODS: This was a retrospective cohort study including preterm neonates who received at least one dose of intravenous indomethacin or ibuprofen as their first treatment course for PDA closure. Patients were categorized into the early treatment (ET) cohort if pharmacologic therapy was initiated on day of life (DOL) 0-7 and to the late treatment (LT) cohort if initiated on DOL 8 or later. PDA closure rate was the primary outcome, and data were also evaluated to assess the need for additional medical or surgical interventions for PDA closure, as well as neonatal safety outcomes based on time to initiation of therapy.
RESULTS: A total of 97 patients with a median gestational age of 25 weeks were included for analysis, with 29 in the ET cohort and 68 in the LT cohort. Baseline characteristics were similar between the ET and LT cohorts, with a median DOL of therapy initiation of 5 (interquartile range 4-6) and 11 (interquartile range 10-13.5) days, respectively. Rates of indomethacin as the initial nonsteroidal anti-inflammatory drug choice were similar between the ET and LT cohorts (66% vs 56%, p = 0.5). There was no difference in PDA closure rates following the initial course of pharmacologic therapy between the ET and LT cohorts (45% vs 32%, p = 0.26). Similarly, there was no difference in the incidence of a second pharmacologic treatment course (25% vs 26%, p = 1), surgical ligation, transcatheter closure, or adverse neonatal outcomes between cohorts.
CONCLUSION: The time to initiation of intravenous indomethacin or ibuprofen did not significantly affect PDA closure rates, the need for subsequent PDA pharmacotherapy, or adverse neonatal outcomes. Overall rates of PDA closure with pharmacologic intervention were low.
PMID:41083809 | DOI:10.1007/s40272-025-00723-4