Document Detail

Meter-dosed, inhaled beclomethasone attenuates bronchoalveolar oxyradical inflammation in premature infants at risk for bronchopulmonary dysplasia.
MedLine Citation:
PMID:  9926878     Owner:  NLM     Status:  MEDLINE    
The object of this study was to examine the hypothesis that meter-dosed, inhaled beclomethasone administered to premature infants beginning at birth in a tapering dosage schedule over the first 12 days of life attenuates bronchoalveolar lining fluid oxyradical inflammation concomitant with modulation of bronchopulmonary dysplasia. The design of this study was an unblinded, uncontrolled phase I, pilot investigation of inhaled beclomethasone primarily examining safety and administration. The setting was a tertiary care neonatal intensive care unit. Intubated, premature infants were studied longitudinally to 36 weeks corrected gestational age. Meter-dosed, inhaled beclomethasone was administered in a tapering dosage schedule over the first 12 days of life. Endotracheal tube aspirates were collected on Days 2, 4, and 6 of life and assayed for various markers of bronchoalveolar lining fluid oxyradical stress. Infants were also assessed with regards to a number of relevant clinical variables and presence or absence of bronchopulmonary dysplasia at 36 weeks corrected gestational age. Although no differences in clinical outcome were apparent in comparing nine control infants with nine beclomethasone-treated infants, bronchoalveolar lining fluid from control infants exhibited evidence of apparent phospholipid peroxidation (enhanced polyunsaturated fatty acid consumption) on Day 2 of life compared to beclomethasone-treated infants. Significant differences were noted for percent arachidonic acid, total polyunsaturated fatty acids and ratio of polyunsaturated fatty acids, to saturated fatty acids. The ratio of monohydroxyl linolenic acid to native linoleic acid (a more specific marker of lipid peroxidation) as well as myeloperoxidase activity (a marker of neutrophil oxyradical stress) tended to be higher in the control group but did not achieve statistical significance for this small subject number study. No adverse reactions related to meter-dosed, inhaled beclomethasone were noted in the treatment group; most specifically no evidence of hypothalamic-pituitary-adrenal axis suppression was noted in either control or beclomethasone-treated infants. Meter-dosed, inhaled beclomethasone in the dosage schedule utilized was safe and appeared to moderate bronchoalveolar lining fluid phospholipid peroxidation. Small numbers of infants entered into the present investigation preclude comments on clinical efficacy because of the likelihood of a statistical type 2 error. However, additional investigations of inhaled beclomethasone initiated at birth in premature infants at risk for bronchopulmonary dysplasia, enrolling larger number of subjects and perhaps a higher dosage of beclomethasone, are warranted.
J J Zimmerman; D Gabbert; C Shivpuri; S Kayata; W Ciesielski; J Miller; M E Peters; R P Eissenstat; G Shen
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  American journal of perinatology     Volume:  15     ISSN:  0735-1631     ISO Abbreviation:  Am J Perinatol     Publication Date:  1998  
Date Detail:
Created Date:  1999-04-14     Completed Date:  1999-04-14     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8405212     Medline TA:  Am J Perinatol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  567-76     Citation Subset:  IM    
University of Wisconsin Children's Hospital, Division of Critical Care Medicine, Madison, Wisconsin, USA.
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MeSH Terms
Administration, Inhalation
Beclomethasone / administration & dosage*,  adverse effects
Bronchoalveolar Lavage Fluid / chemistry
Bronchopulmonary Dysplasia / drug therapy*
Fatty Acids / analysis,  metabolism
Gestational Age
Hypothalamo-Hypophyseal System / drug effects
Infant, Newborn
Infant, Premature
Interleukin-8 / analysis
Lipid Peroxidation
Lung Diseases / drug therapy*
Nebulizers and Vaporizers
Peroxidase / analysis
Phospholipids / analysis
Pilot Projects
Pituitary-Adrenal System / drug effects
Reactive Oxygen Species
Severity of Illness Index
Grant Support
Reg. No./Substance:
0/Fatty Acids; 0/Interleukin-8; 0/Phospholipids; 0/Reactive Oxygen Species; 4419-39-0/Beclomethasone; EC

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