Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial.

Objective: To investigate neurodevelopmental outcome after hydrocortisone (HC) supplementation in infants with neonatal encephalopathy (NE) and hypotension.

Study design: Fifty-five infants with volume-resistant hypotension during hypothermia were enrolled between 2016 and 2020. Eligible patients were randomly assigned to receive 0.5 mg/kg HC every 6 h or placebo along with standard dopamine treatment. Composite adverse outcome was defined as death or neurodevelopmental impairment, ascertained using the Bayley-II test.

Result: At median 20 months of age, death, or severe neurodevelopmental impairment occurred in 40% in the HC group, compared to 18% in the placebo group (p = 0.13). Multiple logistic regression analysis showed that for every 1 mg/kg increase in cumulative HC dose, the odds of adverse cognitive outcome increased by 16% (95% CI 1.01-1.37; p = 0.04).

Conclusion: The composite outcomes were similar in the HC-treated and placebo groups, however cumulative HC dose was associated with adverse cognitive outcome in infants with NE and hypotension.

Clinical trial registration: Hydrocortisone treatment in systemic low blood pressure during hypothermia in asphyxiated newborns (CORTISoL), ClinicalTrials.gov ID: NCT02700828 https://clinicaltrials.gov/ct2/show/NCT02700828 , date of registration: 2016-02-24.