title: A prospective clinical study on inhaled nitric oxide therapy for neonates in Japan.
abstract: BACKGROUND
  This is the first report about a prospective clinical investigation to study the efficacy and safety of nitric oxide (NO) inhalation in infants with persistent pulmonary hypertension of the newborn (PPHN) in Japan.
  
  
  METHODS
  Patients in the present study had to meet the following entry criteria: (i) they had to be younger than 7 days of age; (ii) they had to have evidence of PPHN as defined by echocardiograph; (iii) they had to have severe systemic hypoxemia under mechanical ventilation at 100% oxygen supplementation; and (iv) they had to have a failure to respond to conventional therapies. Patients were excluded from this trial if they had any of the following: hypoplastic lung, structural cardiac lesions or severe multiple anomalies.
  
  
  RESULTS
  Nitric oxide inhalation therapy was performed in 68 infants who had severe PPHN at 18 hospitals between May 1995 and May 1997. At birth, 21 of 68 infants (31%) weighed less than 1,500 g and 39 infants weighed more than 2,500 g. The diagnoses associated with PPHN were as follows: 27 infants had meconium aspiration syndrome, 15 infants had dry lung syndrome, nine infants had congenital diaphragmatic hernia, six infants had respiratory distress syndrome, three infants had pneumonia and eight infants had other diagnoses. The mean oxygenation index (OI) before NO inhalation therapy in 68 infants was 43.2; 55 infants (81%) had good responses.
  
  
  CONCLUSIONS
  These results may be valuable for further randomized controlled and double-blind trials in Japan to evaluate whether NO inhalation therapy is more effective than conventional therapy in infants with severe PPHN.
authors.affiliation: Department of Pediatrics, Nagoya City University Medical School, Nagoya, Japan. yamaguti@med.nagoya-cu.ac.jp
authors.forename: N
authors.initials: N
authors.lastname: Yamaguchi
authors.forename: H
authors.initials: H
authors.lastname: Togari
authors.forename: M
authors.initials: M
authors.lastname: Takase
authors.forename: S
authors.initials: S
authors.lastname: Hattori
authors.forename: S
authors.initials: S
authors.lastname: Yamanami
authors.forename: H
authors.initials: H
authors.lastname: Hasegawa
authors.forename: R
authors.initials: R
authors.lastname: Hoshino
authors.forename: M
authors.initials: M
authors.lastname: Tamura
authors.forename: S
authors.initials: S
authors.lastname: Mimura
authors.forename: S
authors.initials: S
authors.lastname: Suzuki
authors.forename: M
authors.initials: M
authors.lastname: Futamura
authors.forename: H
authors.initials: H
authors.lastname: Aotani
authors.forename: K
authors.initials: K
authors.lastname: Sumi
authors.forename: S
authors.initials: S
authors.lastname: Kusuda
authors.forename: H
authors.initials: H
authors.lastname: Ichiba
authors.forename: L
authors.initials: L
authors.lastname: Yong-Kye
authors.forename: Y
authors.initials: Y
authors.lastname: Uetani
authors.forename: H
authors.initials: H
authors.lastname: Nakao
authors.forename: R
authors.initials: R
authors.lastname: Higuchi
mesh_terms: D000280:Administration, Inhalation; D006801:Humans; D007231:Infant, Newborn; D007564:Japan; D009569:Nitric Oxide / Q000008:administration & dosage* / Q000009:adverse effects; D010100:Oxygen / Q000097:blood; D010547:Persistent Fetal Circulation Syndrome / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D009569:Nitric Oxide; D010100:Oxygen