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An investigation examines whether a treatment of hydrocortisone could lead to a reduction in moderate to severe bronchopulmonary dysplasia and neurodevelopmental outcomes at age 2 years.
One complication for an extremely preterm birth is bronchopulmonary dysplasia, which may develop as a result of inflammation along with mechanical ventilation. A potential treatment course is hydrocortisone, but its efficacy when used after the second postnatal week was poorly understood. A report examined whether it could lead to an improvement in survival with both bronchopulmonary dysplasia and adverse neurodevelopmental effects.1
The investigators ran a trial that included infants who had a gestational age of less than 30 weeks and had been intubated for at least 7 days at 14 to 28 days of life. They randomly assigned the infants to either receive a placebo or hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days). The trial’s primary efficacy outcome was an infant’s survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age and the primary safety outcome was survival with no moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age.
A total of 800 infants were enrolled with an average birth weight of 715±167 g and a mean gestational age, 24.9±1.5 weeks. The primary efficacy endpoint was achieved by 66 out of 398 infants in the hydrocortisone group and 53 out of 402 in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Ninety-one percent of the infants had 2-year outcomes information available. The safety endpoint was reached by 132 of 358 infants in the hydrocortisone group and 134 of 359 in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Although adverse events were generally the same across both groups, the group that received hydrocortisone was found to have hypertension requiring medication more frequently than the placebo group (4.3% vs 1.0%).
The investigators concluded that the use of hydrocortisone treatment at day 14 of life in preterm infants was not associated with a significantly higher rate of survival without the complication than placebo. Furthermore, the rate of survival without moderate or severe neurodevelopmental impairment was not found to be substantially different between the groups.
1. Watterberg K, Walsh M, Li L, et al. Hydrocortisone to improve survival without bronchopulmonary dysplasia. N Engl J Med. 2022; 386:1121-1131 dot: 10.1056/NEJMoa2114897