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Early low-dose hydrocortisone: is the neurodevelopment affected?
Gaston Ofman1, Marta Perez2, Kathryn N Farrow2
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA. gaston.ofman@northwestern.edu.
Insights
Early low-dose hydrocortisone in extremely preterm infants did not significantly impact neurodevelopmental outcomes at two years. This finding suggests hydrocortisone treatment is not associated with adverse neurodevelopmental effects in this vulnerable population.
Area of Science:
- Neonatal Medicine
- Pediatric Neurology
- Clinical Trials
Background:
- Extremely preterm infants (<28 weeks gestation) face high risks of neurodevelopmental impairment.
- Early interventions are crucial to improve outcomes in this population.
- The neurodevelopmental effects of early low-dose hydrocortisone in extremely preterm infants remain an area of investigation.
Purpose of the Study:
- To investigate the association between early low-dose hydrocortisone and neurodevelopmental impairment at two years of age in extremely preterm infants.
- To analyze the exploratory secondary outcomes of a randomized controlled trial (PREMILOC).
Main Methods:
- An exploratory secondary analysis of the PREMILOC trial, a double-blind, multicenter, randomized, placebo-controlled study.
- Infants born between 24 0/7 and 27 6/7 weeks gestation received either low-dose hydrocortisone or placebo for 10 days.
- Neurodevelopmental outcomes were assessed at 22 months corrected age.
Main Results:
- No statistically significant differences were observed in the rates of no neurodevelopmental impairment (73% vs. 70%), mild impairment (20% vs. 18%), or moderate to severe impairment (7% vs. 11%) between the hydrocortisone and placebo groups (p=0.33).
- Qualitative neurological assessments also showed no significant differences between the groups (p=0.87).
Conclusions:
- Early low-dose hydrocortisone treatment in extremely preterm infants was not associated with adverse neurodevelopmental effects at 22 months corrected age.
- These findings support the safety of this hydrocortisone regimen regarding neurodevelopmental outcomes in this population.
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.
