Expectant Management Matches Active Treatment in Preemies With Patent Ductus Arteriosus

WEDNESDAY, Dec. 17, 2025 (HealthDay News) -- For extremely preterm infants with protocol-defined patent ductus arteriosus (PDA), the incidence of death or bronchopulmonary dysplasia (BPD) does not differ with expectant management versus active treatment, according to a study published online Dec. 9 in the Journal of the American Medical Association.Matthew M. Laughon, M.D., M.P.H., from the University of North Carolina at Chapel Hill, and colleagues conducted a randomized clinical trial involving infants born at 22 to 28 weeks of gestation and diagnosed with a protocol-defined PDA between the ages of 48 hours and 21 days. Infants with PDA were randomly assigned to receive either expectant management or active treatment (acetaminophen, ibuprofen, or indomethacin) to close the PDA (242 and 240 infants, respectively).After the 50 percent interim analysis for the primary outcome of death at 36 weeks of postmenstrual age, the trial was stopped for futility and safety due to higher survival in the expectant management group. The researchers found that the incidence of death or BPD was 80.9 and 79.6 percent in the expectant management and active treatment groups, respectively (adjusted risk difference, 1.2 percent; 95 percent confidence interval, −5.7 to 8.1 percent; P = 0.73). The incidence of death before 36 weeks of postmenstrual age was 4.1 and 9.6 percent in the expectant management and active treatment groups, respectively (adjusted risk difference, −5.6 percent; 95 percent confidence interval, −10.1 to −1.2 percent; P = 0.01). Infections resulting in death occurred in 0.8 and 3.8 percent in the expectant management and active treatment groups, respectively."This trial showed no benefit of active treatment of the PDA in extremely preterm infants," Laughon said in a statement. "In fact, it identified a higher chance of survival for expectant management, consistent with emerging data on the effects of early (i.e., prior to one or two weeks after birth) pharmacologic PDA treatment."Several authors disclosed ties to the biopharmaceutical industry.Abstract/Full Text.Sign up for our weekly HealthDay newsletter

Expectant Management Matches Active Treatment in Preemies With Patent Ductus Arteriosus

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