title: A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn.
abstract: OBJECTIVE
  To assess the efficacy and safety of bosentan as an adjuvant therapy of persistent pulmonary hypertension of the newborn (PPHN).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Bosentan may be a useful adjuvant therapy of PPHN.
authors.affiliation: Department of Pediatrics, El-Minia University, El-Minia, Egypt. walidabdo2020@gmail.com
authors.forename: W A
authors.initials: WA
authors.lastname: Mohamed
authors.forename: M
authors.initials: M
authors.lastname: Ismail
mesh_terms: D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077300:Bosentan; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan