
The Incubator #386 - 🟢 HOT TOPICS 2025 COVERAGE - Discussing the results of the PDA trial with Dr. Matthew Laughon
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Dec 9, 2025 Dr. Matthew Laughon discusses a groundbreaking study on PDA management, revealing that expectant management has significantly lower mortality rates compared to active treatment methods. The trial stopped early due to safety concerns, highlighting the importance of cautious approaches for symptomatic infants. Interestingly, secondary outcomes like BPD and NEC showed no differences, aligning new findings with updated guidelines suggesting minimal routine treatment in the initial weeks. Key challenges of randomization and clinician preferences also emerge as noteworthy points.
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Personal Tragedy Sparked The Trial
- As a trainee, Matthew Laughon treated a baby with PDA who later developed heart failure and died, which motivated his interest in PDA management research.
- That personal experience drove him to question whether closing PDAs improved long-term outcomes and to pursue rigorous trials.
Protocolized Eligibility With A Calculator
- The trial used strict, protocol-defined echocardiogram and clinical criteria with a calculator to identify eligible infants for randomization.
- This systematic approach ensured consistent enrollment and reduced clinician-selection bias across sites.
Follow The Trial's Management Framework
- Randomize symptomatic infants to expectant management versus medical therapy, allowing clinicians to choose indomethacin, ibuprofen, or acetaminophen.
- Permit treatment only if cardiopulmonary compromise develops to preserve trial integrity and safety monitoring.
