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Is Expectant Management Noninferior to Early Ibuprofen for Patent Ductus Arteriosus?

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Summary

In this multicentre non-inferiority trial, 273 infants with echocardiographically confirmed PDA (diameter >1.5 mm) who were extremely preterm (<28 weeks gestational age) underwent randomization 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 median gestational age was 26 weeks, with a median birth weight of 845 g. A primary-outcome event occurred in 63 of 136 infants (46.3%) in the expectant-management group and in 87 of137 (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). The authors concluded that 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.

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Authors and Affiliations

  1. Command Hospital(CC), Lucknow, Uttar Pradesh, India

    Ashutosh Kumar

  2. Department of Pediatrics, PGIMER, Chandigarh, India

    Sourabh Dutta

  3. Department of Neonatology, AIIMS, Jodhpur, Rajasthan, India

    Neeraj Gupta

  4. Department of Pediatrics, University College of Medical Sciences & associated GTB Hospital, Delhi, India

    Sumaira Khalil

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  1. Ashutosh Kumar
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  2. Sourabh Dutta
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  3. Neeraj Gupta
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  4. Sumaira Khalil
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Corresponding authors

Correspondence to Sourabh Dutta, Neeraj Gupta or Sumaira Khalil.

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Source Citation

Hundscheid T, Onland W, Kooi EMW; BeNeDuctus Trial Investigators. Expectant Management or early ibuprofen for patent ductus arteriosus. N Engl J Med. 2023;388:980–90.

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Kumar, A., Dutta, S., Gupta, N. et al. Is Expectant Management Noninferior to Early Ibuprofen for Patent Ductus Arteriosus?. Indian Pediatr 60, 488–491 (2023). https://doi.org/10.1007/s13312-023-2915-0

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  • DOI: https://doi.org/10.1007/s13312-023-2915-0

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