title: Perioperative methylprednisolone and outcome in neonates undergoing heart surgery.
abstract: BACKGROUND
  Recent studies have called into question the benefit of perioperative corticosteroids in children undergoing heart surgery, but have been limited by the lack of placebo control, limited power, and grouping of various steroid regimens together in analysis. We evaluated outcomes across methylprednisolone regimens versus no steroids in a large cohort of neonates.
  
  
  METHODS
  Clinical data from the Society of Thoracic Surgeons Database were linked to medication data from the Pediatric Health Information Systems Database for neonates (≤30 days) undergoing heart surgery (2004-2008) at 25 participating centers. Multivariable analysis adjusting for patient and center characteristics, surgical risk category, and within-center clustering was used to evaluate the association of methylprednisolone regimen with outcome.
  
  
  RESULTS
  A total of 3180 neonates were included: 22% received methylprednisolone on both the day before and day of surgery, 12% on the day before surgery only, and 28% on the day of surgery only; 38% did not receive any perioperative steroids. In multivariable analysis, there was no significant mortality or length-of-stay benefit associated with any methylprednisolone regimen versus no steroids, and no difference in postoperative infection. In subgroup analysis by surgical-risk group, there was a significant association of methylprednisolone with infection consistent across all regimens (overall odds ratio 2.6, 95% confidence interval 1.3-5.2) in the lower-surgical-risk group.
  
  
  CONCLUSIONS
  This multicenter observational analysis did not find any benefit associated with methylprednisolone in neonates undergoing heart surgery and suggested increased infection in certain subgroups. These data reinforce the need for a large randomized trial in this population.
authors.affiliation: Department of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA. sara.pasquali@duke.edu
authors.forename: Sara K
authors.initials: SK
authors.lastname: Pasquali
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Li
authors.forename: Xia
authors.initials: X
authors.lastname: He
authors.forename: Marshall L
authors.initials: ML
authors.lastname: Jacobs
authors.forename: Sean M
authors.initials: SM
authors.lastname: O'Brien
authors.forename: Matthew
authors.initials: M
authors.lastname: Hall
authors.forename: Robert D B
authors.initials: RD
authors.lastname: Jaquiss
authors.forename: Karl F
authors.initials: KF
authors.lastname: Welke
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Samir S
authors.initials: SS
authors.lastname: Shah
authors.forename: J William
authors.initials: JW
authors.lastname: Gaynor
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Jacobs
mesh_terms: D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002423:Cause of Death; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003428:Cross Infection / Q000209:etiology / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D006330:Heart Defects, Congenital / Q000401:mortality / Q000601:surgery*; D006751:Hospital Information Systems / Q000706:statistics & numerical data; D017052:Hospital Mortality; D006801:Humans; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000401:mortality* / Q000601:surgery*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008498:Medical Record Linkage; D008775:Methylprednisolone / Q000008:administration & dosage*; D009894:Opportunistic Infections / Q000209:etiology / Q000401:mortality; D059035:Perioperative Period; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000209:etiology / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone