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Patent ductus arteriosus: emerging trial evidence firmly supports conservative management in preterm infants
Nehal A Parikh1,2,3, Sanjana Velu1,2
1The Perinatal Institute.
Insights
Conservative management of patent ductus arteriosus (PDA) is recommended for very preterm infants. Current evidence shows medical therapies and transcatheter closure do not improve outcomes and may increase risks like bronchopulmonary dysplasia or death.
Area of Science:
- Neonatalogy
- Pediatric Cardiology
- Clinical Trials Research
Background:
- Patent ductus arteriosus (PDA) is common in very preterm infants (<32 weeks' gestation).
- PDA closure therapies are frequently employed, but evidence on their benefits and risks is evolving.
Purpose of the Study:
- To review recent randomized clinical trials (RCTs) and meta-analyses on PDA closure therapies versus conservative management.
- To evaluate the impact on key outcomes like bronchopulmonary dysplasia (BPD) or death in very preterm infants.
Main Methods:
- Systematic review of RCTs and meta-analyses published in the last decade.
- Analysis of outcomes including BPD/death at 36 weeks postmenstrual age and mortality.
Main Results:
- Ten RCTs of medical PDA therapies showed no reduction in moderate-severe BPD/death compared to placebo.
- Meta-analysis of these RCTs indicated an increased risk of BPD/death (RR: 1.10) and mortality (RR: 1.25).
- Recent meta-analyses confirm increased mortality with early medical PDA treatment; transcatheter closure lacks safety/efficacy trials.
Conclusions:
- Conservative PDA management is the evidence-based approach.
- Clinical experimentation with PDA closure is no longer justifiable.
- Expectant management should be the standard of care to uphold the 'first, do no harm' principle.
Purpose Of Review:
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.
Recent Findings:
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.
Summary:
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'.
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