title: Leukotriene receptor blockade as a life-saving treatment in severe bronchopulmonary dysplasia.
abstract: BACKGROUND
  Bronchopulmonary dysplasia (BPD) is a major cause of mortality and morbidity in infants with an extremely low birth weight. Because there is no effective therapy, the mortality of this condition in severely affected patients is high. Therapeutic blocking of the leukotriene system seems to be a logical approach due to the known pathophysiology of BPD.
  
  
  OBJECTIVE
  The aim of this study was to examine the therapeutic effect of montelukast in preterm children suffering from severe BPD.
  
  
  METHODS
  We performed an unblinded, prospective trial including infants born between 23 and 27 weeks of gestation suffering from severe BPD. The study drug was montelukast (1 mg/kg of body weight as a single dose daily in the 1st week of therapy, increasing to 1.5 mg/kg of body weight in the 2nd week and finally to 2 mg/kg of body weight in the 3rd week). Treatment was continued until the radiological signs and the clinical symptoms of BPD disappeared or the patient was discharged from the hospital. Each patient included in this study was matched for gestational age, birth weight, and pulmonary severity score to a control.
  
  
  RESULTS
  Until March 2014, a total of 22 infants were enrolled into the study. The rates of the primary outcome differed significantly between the montelukast-treated group and the control group. All but 1 of the children in the treatment group survived (91%), whereas 7 of the 11 children in the control group died (survival rate 36%; p = 0.002 using Fisher's exact test). The mean mechanical ventilation time (41.2 ± 25.3 vs. 103.7 ± 90.6 days) was significantly shorter and the mean preterm complication score (3.0 ± 1.7 vs. 5.6 ± 1.4) was significantly lower in treated patients compared to the control group. (p = 0.05 for both items; Wilcoxon's matched-pairs test).
  
  
  CONCLUSIONS
  Based on the clinical observations, the statistical results, and the relatively low risk of the study drug montelukast, we recommend using this treatment in severe cases of BPD for infants facing a high risk of death.
authors.affiliation: Institute for Pathology, Children's Hospital Bayreuth, Bayreuth, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rupprecht
authors.forename: Christian
authors.initials: C
authors.lastname: Rupprecht
authors.forename: Dieter
authors.initials: D
authors.lastname: Harms
authors.forename: William
authors.initials: W
authors.lastname: Sterlacci
authors.forename: Michael
authors.initials: M
authors.lastname: Vieth
authors.forename: Kathrin
authors.initials: K
authors.lastname: Seybold
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D001997:Bronchopulmonary Dysplasia / Q000000981:diagnostic imaging / Q000378:metabolism / Q000401:mortality / Q000503:physiopathology / Q000628:therapy; D003521:Cyclopropanes; D054796:Drug Dosage Calculations; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D020024:Leukotriene Antagonists / Q000008:administration & dosage; D008297:Male; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D011859:Radiography; D018077:Receptors, Leukotriene / Q000378:metabolism; D012121:Respiration, Artificial / Q000379:methods*; D012720:Severity of Illness Index; D013440:Sulfides; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D018077:Receptors, Leukotriene; D013440:Sulfides; C093875:montelukast