Document Detail


Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes.
MedLine Citation:
PMID:  23140612     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: 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.
Authors:
Nehal A Parikh; Kathleen A Kennedy; Robert E Lasky; Georgia E McDavid; Jon E Tyson
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-11-08
Journal Detail:
Title:  The Journal of pediatrics     Volume:  162     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-26     Completed Date:  2013-05-16     Revised Date:  2014-04-02    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  685-690.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 Mosby, Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Anthropometry / methods
Brain / drug effects,  pathology*
Brain Injuries / prevention & control
Bronchopulmonary Dysplasia / prevention & control*,  therapy
Female
Humans
Hydrocortisone / therapeutic use*
Infant, Extremely Low Birth Weight
Infant, Newborn
Infant, Premature*
Magnetic Resonance Imaging / methods
Male
Placebos
Reproducibility of Results
Respiration, Artificial
Risk
Treatment Outcome
Grant Support
ID/Acronym/Agency:
K23 NS048152/NS/NINDS NIH HHS; K23-NS048152/NS/NINDS NIH HHS; UL1 RR024148/RR/NCRR NIH HHS; UL1RR024148/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Placebos; WI4X0X7BPJ/Hydrocortisone
Comments/Corrections
Comment In:
J Pediatr. 2013 Apr;162(4):667-70   [PMID:  23527840 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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