Onland W, et al. - Investigators administered hydrocortisone between 7 and 14 days after birth to mechanically ventilated very preterm newborns. They observed that when compared with placebo, found no improvement in the composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age.

Methods

• In this double-blind, placebo-controlled randomized trial conducted in 19 neonatal intensive care units in the Netherlands and Belgium between November 15, 2011, and December 23, 2016, they analyzed preterm neonates with a gestational age of less than 30 weeks and/or birth weight of less than 1.250 kg.
• The newborns were ventilator dependent between 7 and 14 days of life, with follow-up to hospital discharge ending December 12, 2017.
• They assigned the infants randomly to receive a 22-day course of systemic hydrocortisone (cumulative dose, 72.5 mg/kg) (n=182) or placebo (n=190).
• A composite of death or BPD assessed at 36 weeks’ postmenstrual age was the primary outcome.
• They assessed 29 secondary outcomes up to hospital discharge, including death and BPD at 36 weeks’ postmenstrual age.

Results

• A fraction of 371 cases completed the trial among 372 subjects randomized (mean gestational age, 26 weeks; 55% male) as parents withdrew consent for 1 child treated with hydrocortisone.
• They observed death or BPD in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 neonates (73.7%) randomized to placebo (adjusted risk difference, −3.6% [95% CI, −12.7% to 5.4%]; adjusted odds ratio, 0.87 [95% CI, 0.54-1.38]; P =.54).
• They noticed significant differences in 8 secondary outcomes including death at 36 weeks’ postmenstrual age (15.5% with hydrocortisone vs 23.7% with placebo; risk difference, −8.2% [95% CI, −16.2% to −0.1%]; odds ratio, 0.59 [95% CI, 0.35-0.995]; P=.048).
• They found insignificant variations including BPD (55.2% with hydrocortisone vs 50.0% with placebo; risk difference, 5.2% [95% CI, −4.9% to 15.2%]; odds ratio, 1.24 [95% CI, 0.82-1.86]; P=.31) in 21 outcomes.
• They observed hyperglycemia requiring insulin therapy as the single adverse effect recorded more often in the hydrocortisone group (18.2%) as compared to the placebo group (7.9%).