Aim: To assess the 5-year neurocognitive outcomes of children born extremely preterm exposed to prophylactic hydrocortisone to improve survival without bronchopulmonary dysplasia.
Method: This was a prespecified secondary analysis of the PREMILOC clinical trial (trial registration: EudraCT no. 2007-002041-20, NCT00623740). The primary outcome was full-scale IQ based on the Wechsler Preschool and Primary Scale of Intelligence.
Results: Among 109 surviving children recruited at the Robert Debré Children's Hospital, Paris, outcome data were available for 42 out of 56 infants (75%) in the group treated with hydrocortisone and 41 out of 53 (77%) in the placebo group. Mean scores were not significantly different between the two groups on full-scale IQ (hydrocortisone: 91.9 [SD = 13.9], placebo: 86.3 [SD = 15.4]; mean difference = 5.7, 95% confidence interval [CI] = -1.0 to 12.3, p = 0.10); however, working memory and retention ability were significantly better in the group treated with hydrocortisone. In a multivariate logistic regression including potential confounding variables, hydrocortisone treatment was significantly associated with a greater chance to survive at 5 years of age with a full-scale IQ equal to or greater than 90 compared to placebo (adjusted odds ratio = 4.26, 95% CI = 1.47-12.36, p = 0.008).
Interpretation: This exploratory analysis provides reassuring data regarding the long-term neurodevelopmental safety of prophylactic hydrocortisone in infants born extremely preterm.
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