Primary outcome event occurred in more infants in the early-ibuprofen group than the expectant-management group
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Dec. 28, 2022 (HealthDay News) — For infants who are extremely preterm, expectant management is noninferior to early ibuprofen for patent ductus arteriosus (PDA), according to a study published online Dec. 6 in the New England Journal of Medicine to coincide with the Nemours Children’s Health Hot Topics in Neonatology conference, held Dec. 4 to 7 in Washington, D.C.
Tim Hundscheid, M.D., from the Radboud University Medical Center in Nijmegen, Netherlands, and colleagues conducted a multicenter, noninferiority trial involving 273 infants with echocardiographically confirmed PDA (diameter >1.5 mm; left-to-right shunting) who were extremely preterm (median gestational age, 26 weeks). The infants were randomly assigned to receive expectant management or early ibuprofen treatment (136 and 137 infants, respectively).
The researchers found that a primary outcome event (necrotizing enterocolitis, moderate-to-severe bronchopulmonary dysplasia, or death at postmenstrual age of 36 weeks) occurred in 46.3 and 63.5 percent of infants in the expectant-management and early-ibuprofen groups, respectively (absolute risk difference, −17.2 percent; upper boundary of the one-sided 95 percent confidence interval, −7.4; P < 0.001 for noninferiority). Necrotizing enterocolitis occurred in 17.6 and 15.3 percent of patients, respectively; bronchopulmonary dysplasia occurred in 33.3 and 50.9 percent, respectively; and death occurred in 14.0 and 18.2 percent, respectively. The two groups reported similar rates of other adverse outcomes.
“In our trial, the primary-outcome results suggest harm associated with early ibuprofen exposure, largely driven by a higher incidence of moderate-to-severe bronchopulmonary dysplasia in the early-ibuprofen group than in the expectant-management group,” the authors write.
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