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lüll Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes Parikh NA; Kennedy KA; Lasky RE; McDavid GE; Tyson JEJ Pediatr 2013[Apr]; 162 (4): 685-690.e1OBJECTIVE: To test the hypothesis that high-risk ventilator-dependent extremely low birth weight (birth weight =1000 g) infants treated with 7 days of hydrocortisone will have larger total brain tissue volumes than placebo treated infants. STUDY DESIGN: A predetermined sample size of 64 extremely low birth weight infants, between 10-21 days old and ventilator-dependent with a respiratory index score >/=2, were randomized to systemic hydrocortisone (17 mg/kg cumulative dose) or saline placebo. Primary outcome was total brain tissue volume. Volumetric magnetic resonance imaging was performed at 38 weeks postmenstrual age; brain tissue regions were segmented and quantified automatically with a high degree of accuracy and 9 structures were segmented manually. All analyses of regional brain volumes were adjusted by postmenstrual age at magnetic resonance imaging scan. RESULTS: The study groups were similar at baseline and 8 infants died in each arm. Unadjusted total brain tissue volume (mean +/- SD) in the hydrocortisone (N = 23) and placebo treated infants (N = 21) was 272 +/- 40.3 cm(3) and 277.8 +/- 59.1 cm(3), respectively (adjusted mean difference: 6.35 cm(3) (95% CI: (-20.8, 32.5); P = .64). Three of the 31 hydrocortisone treated infants and 5 of the 33 placebo treated infants survived without severe bronchopulmonary dysplasia (relative risk 0.62, 95% CI: 0.13, 2.66; P = .49). No significant differences were noted in prespecified secondary outcomes of regional structural volumes or days on respiratory support. No adverse effects of hydrocortisone were observed. CONCLUSIONS: Low dose hydrocortisone in high-risk ventilator-dependent infants after a week of age had no discernible effect on regional brain volumes or pulmonary outcomes prior to neonatal intensive care unit discharge.|*Infant, Premature[MESH]|Anthropometry/methods[MESH]|Brain Injuries/prevention & control[MESH]|Brain/drug effects/*pathology[MESH]|Bronchopulmonary Dysplasia/*prevention & control/therapy[MESH]|Female[MESH]|Humans[MESH]|Hydrocortisone/*therapeutic use[MESH]|Infant, Extremely Low Birth Weight[MESH]|Infant, Newborn[MESH]|Magnetic Resonance Imaging/methods[MESH]|Male[MESH]|Placebos[MESH]|Reproducibility of Results[MESH]|Respiration, Artificial[MESH]|Risk[MESH]|Treatment Outcome[MESH] |