title: Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group.
abstract: BACKGROUND
  Inhaled nitric oxide improves gas exchange in neonates, but the efficacy of low-dose inhaled nitric oxide in reducing the need for extracorporeal membrane oxygenation has not been established.
  
  
  METHODS
  We conducted a clinical trial to determine whether low-dose inhaled nitric oxide would reduce the use of extracorporeal membrane oxygenation in neonates with pulmonary hypertension who were born after 34 weeks' gestation, were 4 days old or younger, required assisted ventilation, and had hypoxemic respiratory failure as defined by an oxygenation index of 25 or higher. The neonates who received nitric oxide were treated with 20 ppm for a maximum of 24 hours, followed by 5 ppm for no more than 96 hours. The primary end point of the study was the use of extracorporeal membrane oxygenation.
  
  
  RESULTS
  Of 248 neonates enrolled, 126 were randomly assigned to the nitric oxide group and 122 to the control group. Extracorporeal membrane oxygenation was used in 78 neonates in the control group (64 percent) and in 48 neonates in the nitric oxide group (38 percent) (P=0.001). The 30-day mortality rate in the two groups was similar (8 percent in the control group and 7 percent in the nitric oxide group). Chronic lung disease developed less often in neonates treated with nitric oxide than in those in the control group (7 percent vs. 20 percent, P=0.02). The efficacy of nitric oxide was independent of the base-line oxygenation index and the primary pulmonary diagnosis.
  
  
  CONCLUSIONS
  Inhaled nitric oxide reduces the extent to which extracorporeal membrane oxygenation is needed in neonates with hypoxemic respiratory failure and pulmonary hypertension.
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC, USA. reese_clark@mail.pediatrix.com
authors.forename: R H
authors.initials: RH
authors.lastname: Clark
authors.forename: T J
authors.initials: TJ
authors.lastname: Kueser
authors.forename: M W
authors.initials: MW
authors.lastname: Walker
authors.forename: W M
authors.initials: WM
authors.lastname: Southgate
authors.forename: J L
authors.initials: JL
authors.lastname: Huckaby
authors.forename: J A
authors.initials: JA
authors.lastname: Perez
authors.forename: B J
authors.initials: BJ
authors.lastname: Roy
authors.forename: M
authors.initials: M
authors.lastname: Keszler
authors.forename: J P
authors.initials: JP
authors.lastname: Kinsella
mesh_terms: D000280:Administration, Inhalation; D002908:Chronic Disease; D015199:Extracorporeal Membrane Oxygenation; D006801:Humans; D007231:Infant, Newborn; D008171:Lung Diseases / Q000517:prevention & control; D009569:Nitric Oxide / Q000008:administration & dosage*; D010547:Persistent Fetal Circulation Syndrome / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D012121:Respiration, Artificial; D012131:Respiratory Insufficiency / Q000188:drug therapy* / Q000628:therapy; D016037:Single-Blind Method
chemical_list: D009569:Nitric Oxide