Pilot Randomized Trial of Hydrocortisone in Ventilator-Dependent Extremely Preterm Infants: Effects on Regional Brain Volumes

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• 作者：Nehal A. Parikh ; DO ; MS¹ ; ³ ; ^{Nehal.Parikh@NationwideChildrens.org} ; Kathleen A. Kennedy ; MD ; MPH¹ ; ² ; Robert E. Lasky ; PhD¹ ; ² ; Georgia E. McDavid ; RN¹ ; Jon E. Tyson ; MD ; MPH¹ ; ²
• 关键词：BPD ; Bronchopulmonary dysplasia ; BW ; Birth weight ; ELBW ; Extremely low birth weight ; IV ; Intravenous ; MRI ; Magnetic resonance imaging
• 刊名：The Journal of Pediatrics
• 出版年：2013
• 出版时间：April, 2013
• 年：2013
• 卷：162
• 期：4
• 页码：685-690.e1
• 全文大小：209 K

文摘

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Objective

To test the hypothesis that high-risk ventilator-dependent extremely low birth weight (birth weight ¡Ü1000 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 ¡Ý2, 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 ¡À SD) in the hydrocortisone (N = 23) and placebo treated infants (N = 21) was 272 ¡À 40.3 cm³ and 277.8 ¡À 59.1 cm³, respectively (adjusted mean difference: 6.35 cm³ (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.