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The New England Journal of MedicineExpectant Management or Early Ibuprofen for Patent Ductus Arteriosus

Reevaluating PDA Management in Preterm Infants: A Shift Toward Expectant Strategies

In an era where precision in neonatal care is paramount, a recent multicenter noninferiority trial challenges the conventional approach to managing patent ductus arteriosus (PDA) in extremely preterm infants. This study rigorously compares expectant management to early ibuprofen intervention, offering pivotal insights that could recalibrate clinical strategies and optimize patient outcomes.

Key Points:

  • The trial focused on extremely preterm infants (<28 weeks’ gestational age) with echocardiographically confirmed PDA, comparing expectant management to early ibuprofen treatment.
  • The primary composite outcome was the occurrence of necrotizing enterocolitis, moderate-to-severe bronchopulmonary dysplasia, or death at 36 weeks’ postmenstrual age.
  • Expectant management was found to be noninferior to early ibuprofen treatment regarding the primary composite outcome, with a significant absolute risk difference favoring expectant management.
  • Specifically, the incidence of moderate-to-severe bronchopulmonary dysplasia was significantly lower in the expectant-management group compared to the early-ibuprofen group.
  • There were no significant differences between the two groups in terms of the rates of necrotizing enterocolitis or death.
  • Adverse event rates were similar between the groups, underscoring the safety profile of both management strategies.
  • The trial’s robust design included a multicenter, randomized controlled methodology, enhancing the generalizability of its findings.
  • Despite not reaching the anticipated sample size, the trial’s outcomes were statistically significant, indicating a potential shift in the management paradigm for PDA in preterm infants.

The incidence of persistent PDA correlates inversely with birth weight and gestational age, seen in about 30% of infants born with a birth weight less than 1500 grams, 40% of infants weighing 751-1000 grams, and more than 50% of those weighing 501-750 grams.


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