- 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.
- 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).
- 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.
- Underpowered to detect small differences.