title: The safety and efficacy of nitric oxide therapy in premature infants.
abstract: OBJECTIVE
  To assess the safety-efficacy balance of low-dose inhaled nitric oxide (iNO) in hypoxemic premature infants because no sustained beneficial effect has been demonstrated clearly and there are concerns about side effects.
  
  
  METHODS
  Eight hundred and sixty infants <32 weeks were randomized at birth to receive 5 ppm iNO or placebo when they presented with hypoxemic respiratory failure (HRF) defined by a requirement for mechanical ventilation, fraction of inspired oxygen (FIO 2 ) >40%, and arterio-alveolar ratio in oxygen (aAO 2 ) <0.22. The primary end point was intact survival at 28 days of age.
  
  
  RESULTS
  Sixty-one of 415 infants presented with HRF and were compared with 84 of 445 controls who presented with HRF. There was no difference in the primary end point (61.4% in infants [23% with HRF who were treated with iNO] vs 61.1% in controls [21.4% in controls with HRF]; P = .943). For the infants with HRF who were treated with iNO, there was no significant difference from controls for intraventricular hemorrhage (IVH) (6% vs 7%), necrotizing enterocolitis (8% vs 6 %), or patent ductus arteriosus (PDA) (34% vs 37%). Compared with nonhypoxemic infants, the risk of bronchopulmonary displasia (BPD) increased significantly in HRF controls (OR = 3.264 [CI 1.461-7.292]) but not in infants with HRF who were treated with iNO (OR = 1.626 [CI 0.633-4.178]).
  
  
  CONCLUSIONS
  iNO appears to be safe in premature infants but did not lead to a significant improvement in intact survival on day 28.
authors.affiliation: Neonatology Department, Maternite Regionale Universitaire, Nancy, France. jm.hascoet@maternite.chu-nancy.fr
authors.forename: J M
authors.initials: JM
authors.lastname: Hascoet
authors.forename: J
authors.initials: J
authors.lastname: Fresson
authors.forename: O
authors.initials: O
authors.lastname: Claris
authors.forename: I
authors.initials: I
authors.lastname: Hamon
authors.forename: J
authors.initials: J
authors.lastname: Lombet
authors.forename: A
authors.initials: A
authors.lastname: Liska
authors.forename: S
authors.initials: S
authors.lastname: Cantagrel
authors.forename: J
authors.initials: J
authors.lastname: Al Hosri
authors.forename: G
authors.initials: G
authors.lastname: Thiriez
authors.forename: V
authors.initials: V
authors.lastname: Valdes
authors.forename: G
authors.initials: G
authors.lastname: Vittu
authors.forename: L
authors.initials: L
authors.lastname: Egreteau
authors.forename: A
authors.initials: A
authors.lastname: Henrot
authors.forename: M C
authors.initials: MC
authors.lastname: Buchweiller
authors.forename: P
authors.initials: P
authors.lastname: Onody
mesh_terms: D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology; D002543:Cerebral Hemorrhage / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D000860:Hypoxia / Q000188:drug therapy* / Q000401:mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000401:mortality / Q000628:therapy*; D008297:Male; D015999:Multivariate Analysis; D009569:Nitric Oxide / Q000008:administration & dosage*; D012121:Respiration, Artificial; D012131:Respiratory Insufficiency / Q000401:mortality / Q000628:therapy*; D012189:Retrospective Studies; D012307:Risk Factors; D012449:Safety
chemical_list: D001993:Bronchodilator Agents; D009569:Nitric Oxide