title: Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns.
abstract: OBJECTIVE
  To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation.
  
  
  METHODS
  We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes.
  
  
  RESULTS
  There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P = .86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; P = .89), duration of mechanical ventilation (9.7 vs 8.4 days; P = .27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P = .68).
  
  
  CONCLUSIONS
  We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.
authors: Pediatric Heart Lung Center, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, Section of Neonatology, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO. Electronic address: john.kinsella@ucdenver.edu.
authors: John P
authors: JP
authors: Kinsella
authors: Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham, AL.
authors: Gary R
authors: GR
authors: Cutter
authors: University of California-Davis Children's Hospital, Sacramento, CA.
authors: Robin H
authors: RH
authors: Steinhorn
authors: Nationwide Children's Hospital, Columbus, OH.
authors: Leif D
authors: LD
authors: Nelin
authors: Vanderbilt University Medical Center, Nashville, TN.
authors: William F
authors: WF
authors: Walsh
authors: University of California-San Diego, La Jolla, CA.
authors: Neil N
authors: NN
authors: Finer
authors: Pediatric Heart Lung Center, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, Section of Pulmonary Medicine, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO.
authors: Steven H
authors: SH
authors: Abman
mesh_terms: D000280:Administration, Inhalation; D001997:Bronchopulmonary Dysplasia / Q000209:etiology / Q000517:prevention & control*; D061345:Early Medical Intervention / Q000379:methods; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000401:mortality / Q000628:therapy*; D008297:Male; D009569:Nitric Oxide / Q000008:administration & dosage*; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects; D012121:Respiration, Artificial / Q000706:statistics & numerical data
chemical_list: D009569:Nitric Oxide