低出生体重児における動脈管開存症：早期治療を支持する新たな臨床試験エビデンス

To summarize recent evidence from randomized clinical trials (RCT) and meta-analysis of patent ductus arteriosus (PDA) closure therapies versus conservative/expectant management on key outcomes such as bronchopulmonary dysplasia (BPD) or death in very preterm (<32 weeks' gestation) infants.

Of 10 completed RCTs in the past decade of medical therapies before 2 weeks of age to close a PDA, none demonstrated benefit in reducing moderate-severe BPD/death by 36 weeks postmenstrual age as compared to placebo treatment. When combined, the meta-analysis of the 10 RCTs showed an elevated risk of BPD/death [relative risk (RR): 1.10, 95% confidence interval (CI), 1.01-1.19) and higher risk of death by 36 weeks postmenstrual age or discharge (RR: 1.25; 95% CI, 1.01-1.56). A 2025 Cochrane meta-analysis also found a similar concerning trend of increased mortality following early medical treatment for PDA. Despite their recent popularity, there are no published trials demonstrating safety or efficacy of transcatheter PDA closure.

We now have ample evidence for all clinicians to finally acknowledge that conservative PDA management is the correct path forward. Clinical experimentation is no longer acceptable, and expectant PDA management must be adopted as the current standard if we are to adhere to our foundational principle, 'first, do no harm'.