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A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn

Journal of Perinatology volume 32, pages 608–613 (2012)Cite this article

Subjects

Abstract

Objective:

To assess the efficacy and safety of bosentan as an adjuvant therapy of persistent pulmonary hypertension of the newborn (PPHN).

Study Design:

Forty-seven neonates with PPHN were randomly assigned to receive either bosentan (n=24) or placebo (n=23). Efficacy was evaluated with a favorable outcome defined as fulfilling all the following criteria (for example, oxygenation index <15, normal pulmonary artery pressure (<20 mm Hg) and no premature discontinuation of the drug because of drug-related toxicity or lack of efficacy). Evaluation of safety was done by monitoring drug-related adverse events.

Result:

Bosentan treatment was superior to placebo with a favorable response in 87.5% of patients treated with bosentan as compared with 20% of those who received placebo (P<0.0001). None of patients in the bosentan group had drug-related clinical or laboratory adverse events.

Conclusion:

Bosentan may be a useful adjuvant therapy of PPHN.

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Acknowledgements

The authors acknowledge the major contribution of pediatric cardiologists and colleagues at the neonatal intensive care unit, Abha General Hospital.

Author information

Authors and Affiliations

  1. Department of Pediatrics, El-Minia University, El-Minia, Egypt

    W A Mohamed

  2. Department of Pediatrics, College of Medicine, King Khalid University, Abha, Saudi Arabia

    W A Mohamed

  3. Department of Clinical Pharmacy, Zagazig University, Zagazig, Egypt

    M Ismail

  4. Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha, Saudi Arabia

    M Ismail

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  1. W A Mohamed
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  2. M Ismail
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Correspondence to W A Mohamed.

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The authors declare no conflict of interest.

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Mohamed, W., Ismail, M. A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn. J Perinatol 32, 608–613 (2012). https://doi.org/10.1038/jp.2011.157

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