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.