Thread by @vikkypaedia

Ibuprofen is commonly used in #neonates with PDA, but its benefit is uncertain.
this is a multicenter, noninferiority trial, PDA (dia, >1.5 mm, with L-R shunting) who were extr preterm (<28 weeks’ GA) to receive either expectant management or early ibuprofen Tx
#MedEd #MedTwitter

The noninferiority of expectant Mx as compared with early ibuprofen Tx was defined as an abs risk diff with an upper boundary of the one-sided 95% CI of < 10 %ge pts.

A total of 273 infants underwent randomization. The median gestational age was 26 weeks, and the median birth weight was 845 g.

The composite prim outcome included NEC (Bell’s stage IIa or >), mod- sev BPD, or death at 36 wks’ Post Menstrual age.

A primary-outcome event occurred in 63 of 136 infants (46.3%) in the expectant-management group and in 87 of 137 (63.5%) in the early-ibuprofen group (abs risk difference, −17.2 %ge points; upper boundary of the one-sided 95% CI, −7.4; P<0.001 for noninferiority).

The composite prim outcome included NEC (Bell’s stage IIa or >), mod- sev BPD, or death at 36 wks’ Post Menstrual age.

bronchopulmonary dysplasia occurred in 39 of 117 infants (33.3%) and in 57 of 112 (50.9%), respectively (absolute risk difference, −17.6 percentage points; two-sided 95% CI, −30.2 to −5.0).

Necrotizing enterocolitis occurred in 24 of 136 infants (17.6%) in the expectant-management group and in 21 of 137 (15.3%) in the early-ibuprofen group (absolute risk difference, 2.3 percentage points; two-sided 95% CI, −6.5 to 11.1)

Death occurred in 19 of 136 infants (14.0%) and in 25 of 137 (18.2%), respectively (absolute risk difference, −4.3 percentage points; two-sided 95% CI, −13.0 to 4.4).

Rates of other adverse outcomes were similar in the two groups.

Expectant management for PDA in extremely premature infants was noninferior to early ibuprofen treatment with respect to necrotizing enterocolitis, bronchopulmonary dysplasia, or death at 36 weeks’ postmenstrual age.