Association Between Early Low-Dose Hydrocortisone Therapy in Extremely Preterm Neonates and Neurodevelopmental Outcomes at 2 Years of Age

Abstract

clinicaltrials.gov Identifier: NCT00623740.

Two-year neurodevelopmental outcomes of extremely preterm infants treated with early hydrocortisone: treatment effect according to gestational age at birth

“…These findings are consistent with those previously reported in the entire population recruited in the trial 5. In particular, no difference was detectable between treatment groups in infants born at 26 and 27 weeks gestational age.…”

“…A severity scale was defined according to this scoring system as no, mild or moderate-to-severe disability, yielding a global score based on the lowest subscore as previously reported (see online supplementary file 1). 5 …”

“…Postnatal dexamethasone therapy was found to be associated with short-term benefits, but increased incidence of adverse neurodevelopmental events 3. In the PREMILOC randomised clinical trial of infants born at 24–27 weeks of gestation, conducted between 2008 and 2014 in 21 neonatal intensive care units, early low-dose hydrocortisone therapy was shown to confer a significant, 9 percentage point increase in the rate of BPD-free survival at 36 weeks of postmenstrual age (PMA)4 without adverse neurodevelopmental outcomes at 2 years of age in the overall population 5. To identify possible differences in treatment effect among recruited patients, randomisation was stratified by gestational age at birth (24–25 and 26–27 weeks of gestation).…”

Can We Prevent Bronchopulmonary Dysplasia?

“…30 A recent RCT using low dose hydrocortisone in ELBW infants showed increased survival without BPD 31 and without significant neurodevelopmental effects at 2 years of age. 32 Early inhaled budesonide versus placebo in ELBW infants reduced BPD but there was a concerning trend toward increased mortality. 33 A meta-analysis of 10 trials of early inhaled steroids in infants <1500 grams showed decreased BPD among survivors (RR 0.76, 95% CI 0.63 to 0.93; NNTB 14).…”

Early low-dose hydrocortisone: is the neurodevelopment affected?

“…In this study, Baud et al [10] utilizes secondary analysis to investigate the neurodevelopmental outcome after early low-dose hydrocortisone exposure. Secondary analysis is meant to study additional events of interest, which the primary study is not specifically powered to assess.…”