# Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus — GCMD Library

<p>Another article you should know by Cecilia Gigena</p>

<p>"Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus" </p>

<p><strong>Authors:</strong> <em>Tim Hundscheid, M.D., Wes Onland, M.D., Ph.D., Elisabeth M.W. Kooi, M.D., Ph.D., Daniel C. Vijlbrief, M.D., Ph.D., Willem B. de Vries, M.D., Ph.D., Koen P. Dijkman, M.D., Anton H. van Kaam, M.D., Ph.D., Eduardo Villamor, M.D., Ph.D., André A. Kroon, M.D., Ph.D., Remco Visser, M.D., Ph.D., Susanne M. Mulder-de Tollenaer, M.D., Barbara De Bisschop, M.D</em></p>

<p><strong>Full article:</strong> <a href="http://nejm.org/doi/full/10.1056/NEJMoa2207418">nejm.org/doi/full/10.1056/NEJMoa2207418</a></p>

<p>BACKGROUND</p>

<p>Cyclooxygenase inhibitors are commonly used in infants with patent ductus arteriosus (PDA), but the benefit of these drugs is uncertain.</p>

<p>METHODS</p>

<p>In this multicenter, noninferiority trial, we randomly assigned 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 noninferiority 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.</p>

<p>RESULTS</p>

<p>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 in 87 of 137 (63.5%) in the early-ibuprofen group (absolute risk difference, −17.2 percentage points; upper boundary of the one-sided 95% confidence interval [CI], −7.4; P<0.001 for noninferiority). 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); 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). 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.</p>

<p>CONCLUSIONS</p>

<p>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. </p>

<p> </p>


Type: video · 1 min · posted 2023-08-30
Canonical: https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075

## Chapters
- [0:00](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=0) Trial Results: Expectant Management vs Early Ibuprofen for PDA

## Statements
- "The study was a multi-center non-inferiority trial comparing preterm infants treated with expectant management versus early ibuprofen for PDA" — Cecilia Gigena (clinical) [0:09](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=9)
- "The trial enrolled 273 infants total" — Cecilia Gigena (epidemiological) [0:22](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=22)
- "136 infants were treated with expectant management and 137 with early ibuprofen" — Cecilia Gigena (epidemiological) [0:25](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=25)
- "In the expectant management group, 17.6% developed necrotizing enterocolitis" — Cecilia Gigena (clinical) [0:31](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=31)
- "In the expectant management group, 33% developed bronchopulmonary dysplasia" — Cecilia Gigena (clinical) [0:31](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=31)
- "In the expectant management group, the death rate was 14%" — Cecilia Gigena (clinical) [0:31](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=31)
- "In the ibuprofen group, 15.4% developed necrotizing enterocolitis" — Cecilia Gigena (clinical) [0:43](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=43)
- "In the ibuprofen group, 50% developed bronchopulmonary dysplasia" — Cecilia Gigena (clinical) [0:43](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=43)
- "In the ibuprofen group, the death rate was 80%" — Cecilia Gigena (clinical) [0:43](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=43)
- "Expectant management is not inferior to early ibuprofen in preterm patients with PDA" — Cecilia Gigena (clinical) [1:01](https://library.globalcastmd.com/watch/expectant-management-or-early-ibuprofen-for-patent-ductus-arteriosus-7075?t=61)

## Transcript
Do you use ibuprofen for PDA? Hi, I'm Cecilia Gena from Cincinnati Children's Hospital, and I think this is an article that you should know about. This is a multi-center non-inferiority trial that compared preterm infants treated with expectant management versus early ibuprofen for PDA. And what did they find? They had 273 infants. 136 were treated with expectant management and 137 with early ibuprofen. In the expectant management group, they got 17.6% of necrotizing enterocolitis, 33% of bronchopulmonary dysplasia. And 14% of death rates, whereas in the ibuprofen group, they got 15.4% of necrotizing enterocolitis, 50% of bronchopulmonary dysplasia, and 80% of death rates. So it seems that expectant management is not inferiority that early ibuprofen in preterm patients with PDA. Let us know what you think and stay tuned for more articles that you should know about.

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Not medical advice · citation policy: https://library.globalcastmd.com/ai