Hydrocortisone does not improve risk of death or bronchopulmonary dysplasia in preterm babies: JAMA

Previously a randomized, double-blind, placebo-controlled trial was conducted to investigate the efficacy and safety of systemic hydrocortisone treatment started 7 to 14 days after birth in ventilator-dependent, very preterm infants. However, the trial found no significant difference in the composite primary outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. But, a preplanned exploratory analysis found a reduced risk of death at 36 weeks' postmenstrual age in favor of hydrocortisone.

A study was conducted by a group of researchers from the Netherlands to investigate the prespecified follow-up of mortality and neurodevelopmental impairment (NDI) at 2 years of corrected age.

The study was performed in 16 neonatal intensive care units in the Netherlands and Belgium from November 15, 2011, to December 23, 2016, and with a final follow-up on June 27, 2019. Infants born at a gestational age less than 30 weeks and/or with a birth weight less than 1250 g and ventilator dependent between days 7 and 14 were randomly assigned to either a 22-day course of systemic hydrocortisone or placebo.

The key outcome at 2 years corrected age was a composite of death or Neurodevelopmental impairment (NDI). At 2 years' corrected age, 356 of 371 infants (96%) were evaluated for the outcome of death or NDI.

The results of the study are as follows:

· Out of the total 95 infants died, and neurodevelopment assessment was performed in 95% (262/276) of survivors.

· Baseline characteristics showed a higher parental education level and more multiple births in the hydrocortisone group.

· Occurrence of death or NDI was 56.7% (97/171) in the hydrocortisone group and 62.7% (116/185) in the placebo group.

· The rate of death was 21.5% (39/181) in the hydrocortisone group and 29.5% (56/190) in the placebo group.

· NDI occurred in 43.9% (58/132) of the hydrocortisone group and 46.5% (60/129) of the placebo group.

· The individual NDI domains were not significantly different between the groups.

· Adjustment for preselected risk factors did not change these findings.

The researchers concluded that there was no significant difference in the composite outcome death or NDI at 2 years' corrected age in ventilated very preterm infants treated with systemic hydrocortisone initiated in the second week of life to reduce the risk of death or bronchopulmonary dysplasia. Still, the possible beneficial hydrocortisone effect on survival needs further investigation.

Reference:

Effect of Systemic Hydrocortisone Initiated 7 to 14 Days After Birth in Ventilated Preterm Infants on Mortality and Neurodevelopment at 2 Years' Corrected Age: Follow-up of a Randomized Clinical Trial by Halbmeijer N et. al published in the JAMA.

doi:10.1001/jama.2021.9380