Abstract
Type of investigation:
Prognosis; exploratory secondary analysis of an interventional randomized controlled trial.
Question:
In extremely preterm infant (<28 weeks), is early low-dose hydrocortisone compared to placebo associated with neurodevelopmental impairment at 2 years of age?
Methods:
Patients: Surviving infants enrolled in the PREMILOC trial conducted in France between 2008 and 2014.
Intervention: Double-blind, multicenter, randomized, placebo-controlled trial of infants born between 24 0/7 weeks and 27 6/7 weeks of gestation and before 24 h of postnatal age, assigned to receive either placebo or low-dose hydrocortisone (0.5 mg/kg twice per day for 7 days, followed by 0.5 mg/kg per day for 3 days).
Main results:
For the pre-specified exploratory outcome, the distribution of patients without neurodevelopmental impairment (73% in the hydrocortisone group vs. 70% in the placebo group), with mild neurodevelopmental impairment (20% in the hydrocortisone group vs. 18% in the placebo group), or with moderate to severe neurodevelopmental impairment (7% in the hydrocortisone group vs. 11% in the placebo group) was not found to be statistically significantly different between the two groups (p = 0.33). Qualitative assessment of patients using standardized neurological examination also was not statistically significantly different between groups (p = 0.87).
Study conclusion:
In this follow-up study of premature infants who were randomly assigned at birth to receive low-dose hydrocortisone or placebo for 10 days, hydrocortisone treatment was not associated with any adverse effects on neurodevelopmental outcome at 22 months of corrected age.
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Ofman, G., Perez, M. & Farrow, K.N. Early low-dose hydrocortisone: is the neurodevelopment affected?. J Perinatol 38, 636–638 (2018). https://doi.org/10.1038/s41372-018-0086-y
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DOI: https://doi.org/10.1038/s41372-018-0086-y
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