Primary outcome event occurred in more infants in the early-ibuprofen group than the expectant-management group<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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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<\/em> to coincide with the Nemours Children’s Health Hot Topics in Neonatology conference, held Dec. 4 to 7 in Washington, D.C.<\/p>\n 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).<\/p>\n 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, \u00e2\u0088\u009217.2 percent; upper boundary of the one-sided 95 percent confidence interval, \u00e2\u0088\u00927.4; 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.<\/p>\n “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.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n