title: Early inhaled steroid use in extremely low birthweight infants: a randomised controlled trial.
abstract: OBJECTIVE
  We hypothesised that a prophylactic inhaled steroid would prevent the progression of bronchopulmonary dysplasia (BPD) in extremely low birthweight infants (ELBWIs).
  
  
  METHODS
  This study was a multicentre, randomised, double-blinded, placebo-controlled trial.
  
  
  METHODS
  This investigation was conducted in 12 level III neonatal intensive care units (NICUs).
  
  
  METHODS
  A total of 211 ELBWIs requiring ventilator support were enrolled.
  
  
  METHODS
  Starting within 24 h of birth and continuing until 6 weeks of age or extubation, two doses of 50 μg fluticasone propionate (FP) or placebo were administered every 24 h.
  
  
  METHODS
  The primary outcome measure used to indicate the morbidity of severe BPD incidence was death or oxygen dependence at discharge from the NICU. The secondary measures were neurodevelopmental impairments (NDIs) at 18 months of postmenstrual age and 3 years of age. We performed subgroup analyses based on gestational week (GW) and the presence of chorioamnionitis (CAM).
  
  
  RESULTS
  Infants were randomised into the FP (n=107) or placebo (n=104) groups. No significant differences were detected between the FP and placebo groups with respect to either the frequency of death or the oxygen dependence at discharge or NDIs. In subgroup analyses, the frequencies of death and oxygen dependence at discharge were significantly decreased in the FP group for infants born at 24-26 GWs and for infants with CAM, regardless of the GW at birth.
  
  
  CONCLUSIONS
  Inhaled steroids have no effect on the prevention of severe BPD or long-term NDI but might decrease the severity of BPD for ELBWIs with a risk factor.
  
  
  BACKGROUND
  UMIN-CTR C000000405.
authors.affiliation: Division of Neonatology, Nagano Children's Hospital, Nagano, Japan.|Division of Neonatology, Department of Pediatrics, Shinshu University School of Medicine, Nagano, Japan.
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yonemoto
authors.affiliation: Department of Clinical Laboratory Medicine and Anatomic Pathology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nakayama
authors.affiliation: Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Hirano
authors.affiliation: Department of Pediatrics, Kyoto Kizukawa Hospital, Kyoto, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Aotani
authors.affiliation: Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical Center, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kusuda
authors.affiliation: Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Fujimura
authors.affiliation: Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Tamura
keywords: Neonatology; Respiratory