title: Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Several reports indicate a decreased cortisol response to adrenocorticotropic hormone in preterm infants developing chronic lung disease and in preterm infants with refractory hypotension. Low-dose hydrocortisone (HC) may allow for beneficial effects.
  
  
  OBJECTIVE
  Our aim was to assess whether HC is able to increase survival without chronic lung disease.
  
  
  METHODS
  We performed a double-blind, randomized, placebo-controlled trial. Fifty mechanically ventilated infants (birth weight: 500-1,249 g) were randomized to receive treatment (HC 0.5 mg/kg/12 h for 9 days, then HC 0.5 mg/kg/24 h for 3 days) or placebo. Major outcome was survival without oxygen dependence at 36 weeks of postconceptional age (O(2)-free survival).
  
  
  RESULTS
  The basic characteristics were similar between the two groups. O(2)-free survival was higher in the HC group (64 vs. 32%). The advantage was particularly evident among infants without antenatal steroids. The mortality rate was 16% in the HC group versus 40% in the control group (difference not significant). Hypotension after recruitment was reduced by HC (0 vs. 30%). The incidence of gastrointestinal perforation and other adverse effects was similar between the two groups.
  
  
  CONCLUSIONS
  HC prophylaxis improved O(2)-free survival and early cardiocirculatory function in our population, without important short-term effects. The neurodevelopmental outcome will be assessed at 2 years.
authors.affiliation: Section of Neonatology and Neonatal Intensive Care Unit, Department of Pediatrics, University of Bari, Bari, Italy. fbonsante@libero.it
authors.forename: F
authors.initials: F
authors.lastname: Bonsante
authors.forename: G
authors.initials: G
authors.lastname: Latorre
authors.forename: S
authors.initials: S
authors.lastname: Iacobelli
authors.forename: V
authors.initials: V
authors.lastname: Forziati
authors.forename: N
authors.initials: N
authors.lastname: Laforgia
authors.forename: L
authors.initials: L
authors.lastname: Esposito
authors.forename: A
authors.initials: A
authors.lastname: Mautone
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal; D008297:Male; D010919:Placebos; D017741:Survivors
chemical_list: D010919:Placebos; D003907:Dexamethasone; D006854:Hydrocortisone