Mechanically ventilated, very preterm infants: hydrocortisone does not reduce mortality

  • Onland W & al.
  • JAMA
  • 29 Jan 2019

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Mechanically ventilated very preterm infants who receive hydrocortisone at days 7-14 after birth do not have decreased mortality or bronchopulmonary dysplasia (BPD) risk.

Why this matters

  • Results do not support initiating hydrocortisone as an alternative to dexamethasone.  

Key results

  • Primary outcome of death/BPD in 70.7% of drug group vs 73.7% of placebo group.
    • Adjusted risk difference, −3.6% (95% CI, −12.7% to 5.4%); 
    • aOR, 0.87 (95% CI, 0.54-1.38; P=.54).
  • 29 secondary outcomes; 21 showed no differences.
  • 1 of 8 that differed was death at 36 weeks’ postmenstrual age: 
    • 15.5% hydrocortisone vs 23.7% placebo;  
    • OR, 0.59 (95% CI, 0.35-0.995; P=.048).
  • Difference disappeared by hospital discharge:
    • Hydrocortisone vs placebo, 19.9% vs 28.4%;
    • Crude OR, 0.63 (95% CI, 0.39-1.01; P=.06).
  • The only adverse event more common with intervention was hyperglycemia (18.2% vs 7.9% with placebo).

Study design

  • Double-blind, placebo-controlled randomized controlled trial, the Netherlands and Belgium, November 15, 2011 to December 23, 2016.
  • Enrolled all preterm infants (371 completers), gestational age
  • 22-day hydrocortisone treatment.
  • Outcome: primary was composite of BPD, death, plus 29 secondary outcomes.
  • Funding: Netherlands Organization for Health Research and Development.

Limitations

  • Underpowered to detect small differences.

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