Hydrocortisone fails to improve preterm infant survival without bronchopulmonary dysplasia

Hydrocortisone administered to extremely preterm infants who remained intubated at 14 to 28 days failed to improve survival without moderate or severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age compared with placebo.

“In this multicenter, randomized, placebo-controlled trial involving infants at high risk for bronchopulmonary dysplasia, hydrocortisone treatment did not lead to substantially higher survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age than placebo, nor did hydrocortisone treatment alter the severity of bronchopulmonary dysplasia assessed at that time,” Kristi L. Watterberg, MD, professor of pediatrics at the University of New Mexico Health Sciences Center, Albuquerque, and colleagues wrote in The New England Journal of Medicine.

The trial included 800 infants (mean gestational age, 24.9 weeks; mean birth weight, 715 g) who were intubated for at least 7 days at 14 to 28 days. All infants were randomly assigned to hydrocortisone 4 mg/kg of body weight per day tapered over 10 days (Solu-Cortef plain, Pfizer; n = 398) or placebo (n = 402).

The primary efficacy outcome was survival without moderate to severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age and the primary safety outcome was survival without moderate to severe neurodevelopmental impairment at 22 to 26 months of corrected age, according to the study.

At 36 weeks, survival without moderate or severe bronchopulmonary dysplasia occurred in 16.6% of infants assigned hydrocortisone compared with 13.2% of infants assigned placebo (adjusted incidence rate ratio [aIRR] = 1.27; 95% CI, 0.93-1.74).

Overall, the researchers had 2-year outcomes data available for 91% of infants. In this group, survival without moderate to severe neurodevelopmental impairment occurred in 36.9% of infants assigned hydrocortisone compared with 37.3% of infants assigned placebo (aIRR = 0.98; 95% CI, 0.81-1.18).

Successful extubation occurred more frequently in the hydrocortisone group compared with the placebo group (44.7% vs. 33.6%; IRR = 1.54; 95% CI, 1.23-1.93). Infants assigned hydrocortisone also had fewer days of mechanical ventilation before 36 weeks of postmenstrual age (median, 37 vs. 40 days) and before status of 120 postnatal days (median, 37 vs. 41 days) compared with infants assigned placebo.

Researchers observed more hypertension treated with medication among infants assigned hydrocortisone compared with infants assigned placebo (4.3% vs. 1%; aIRR = 4.27; 95% CI, 1.45-12.55). Other adverse events were similar between both groups.