Expectant management noninferior to early ibuprofen treatment for patent ductus arteriosus
A new study found that with regards to necrotizing enterocolitis, bronchopulmonary dysplasia, or death at 36 weeks' postmenstrual age in extremely premature infants, expectant management for patent ductus arteriosus (PDA) was not less than early ibuprofen treatment. The study results were published in The New England Journal of Medicine.
Patent ductus arteriosus is common in premature infants and its management is still arguable. Cyclooxygenase inhibitors are frequently prescribed to infants with patent ductus arteriosus (PDA), but their efficacy is unknown. Due to the limited evidence, researchers from Netherlands and Belgium conducted a study to assess whether expectant management would be non-inferior to early ibuprofen treatment concerning necrotizing enterocolitis, moderate-to-severe bronchopulmonary dysplasia, or death as assessed at a postmenstrual age of 36 weeks.
A multicenter, noninferiority trial, was carried out by randomly assigning infants with echocardiographically confirmed PDA (diameter, >1.5 mm, with left-to-right shunting) who were extremely preterm (<28 weeks gestational age) to receive either expectant management or early ibuprofen treatment. The composite primary outcome included necrotizing enterocolitis (Bell's stage IIa or higher), moderate to severe bronchopulmonary dysplasia, or death at 36 weeks postmenstrual age. The non-inferiority of expectant management as compared with early ibuprofen treatment was defined as an absolute risk difference with an upper boundary of the one-sided 95% confidence interval of less than 10 percentage points.
RESULTS:
- A total of 273 infants underwent randomization.
- The median gestational age was 26 weeks, and the median birth weight was 845 g.
- A primary-outcome event occurred in 63 of 136 infants (46.3%) in the expectant-management group and 87 of 137 (63.5%) in the early-ibuprofen group (P<0.001 for noninferiority).
- Necrotizing enterocolitis occurred in 24 of 136 infants in the expectant-management group and 21 of 137 in the early-ibuprofen group; bronchopulmonary dysplasia occurred in 39 of 117 infants and 57 of 112, respectively.
- The death occurred in 19 of 136 infants (14.0%) and 25 of 137 (18.2%), respectively (absolute risk difference, −4.3 percentage points; two-sided 95% CI, −13.0 to 4.4).
| outcomes | expectant-management group, | early-ibuprofen group, | absolute risk difference | 95% confidence interval [CI] |
primary-outcome event | 63 (46.3%) n=136 | 87 (63.5%) n=137 | −17.2 percentage points | −7.4 |
Necrotizing enterocolitis | 24 (17.6%) n=136 | 21 (15.3%) n=137 | 2.3 percentage points | −6.5 to 11.1 |
bronchopulmonary dysplasia | 39 (33.3%) n=117 | 57 (50.9%) n=112 | −17.6 percentage points | −30.2 to −5.0 |
- Rates of other adverse outcomes were similar in the two groups.
Thus, the trial showed that expectant management for PDA in extremely premature infants was non-inferior to early ibuprofen treatment.
Further reading: Hundscheid T, Onland W, Kooi EMW, et al. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus [published online ahead of print, 2022 Dec 6]. N Engl J Med. 2022;10.1056/NEJMoa2207418. doi:10.1056/NEJMoa2207418
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