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

J Perinatol. 2012 Aug;32(8):608-13. doi: 10.1038/jp.2011.157. Epub 2011 Nov 10.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Bosentan
  • Double-Blind Method
  • Female
  • Humans
  • Hypertension, Pulmonary / drug therapy*
  • Infant, Newborn
  • Male
  • Prospective Studies
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Treatment Outcome


  • Antihypertensive Agents
  • Sulfonamides
  • Bosentan