Document Detail

Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants: outcome of study participants at 1-year adjusted age.
MedLine Citation:
PMID:  10390254     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Ventilator-dependent preterm infants are often treated with a prolonged tapering course of dexamethasone to decrease the risk and severity of chronic lung disease. The objective of this study was to assess the effect of this therapy on developmental outcome at 1 year of age. METHODS: Study participants were 118 very low birth weight infants who, at 15 to 25 days of life, were not weaning from assisted ventilation and were then enrolled in a randomized, placebo-controlled, double-blind trial of a 42-day tapering course of dexamethasone. Infants were examined at 1 year of age, adjusted for prematurity, by a pediatrician and a child psychologist. A physical and neurologic examination was performed, and the Bayley Scales of Infant Development were administered. All examiners were blind to treatment group. RESULTS: Groups were similar in terms of birth weight, gestational age, gender, and race. A higher percentage of dexamethasone recipients had major intracranial abnormalities diagnosed by ultrasonography (21% vs 11%). Group differences were not found for Bayley Mental Development Index (median [range] for dexamethasone-treated group, 94 [50-123]; for placebo group, 90 [28-117]) or Psychomotor Development Index Index (median [range]) for dexamethasone-treated group, 78 (50-109); for placebo-treated group, 81 [28-117]). More dexamethasone-treated infants had cerebral palsy (25% vs 7%) and abnormal neurologic examination findings (45% vs 16%). In stratified analyses, adjusted for major cranial ultrasound abnormalities, these associations persisted (OR values for cerebral palsy, 5.3; 95% CI: 1.3-21.4; OR values for neurologic abnormality 3.6; 95% CI: 1.2-11.0). CONCLUSIONS: A 42-day tapering course of dexamethasone was associated with an increased risk of cerebral palsy. Possible explanations include an adverse effect of this therapy on brain development and/or improved survival of infants who either already have neurologic injury or who are at increased risk for such injury.
T M O'Shea; J M Kothadia; K L Klinepeter; D J Goldstein; B G Jackson; R G Weaver; R G Dillard
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatrics     Volume:  104     ISSN:  0031-4005     ISO Abbreviation:  Pediatrics     Publication Date:  1999 Jul 
Date Detail:
Created Date:  1999-07-22     Completed Date:  1999-07-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  15-21     Citation Subset:  AIM; IM    
Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
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MeSH Terms
Cerebral Palsy / epidemiology
Child Development / drug effects*
Confounding Factors (Epidemiology)
Dexamethasone / pharmacology*,  therapeutic use
Double-Blind Method
Glucocorticoids / pharmacology*,  therapeutic use
Infant, Newborn
Infant, Very Low Birth Weight*
North Carolina / epidemiology
Odds Ratio
Proportional Hazards Models
Respiratory Distress Syndrome, Newborn / epidemiology,  therapy
Statistics, Nonparametric
Ventilator Weaning / methods*
Reg. No./Substance:
0/Glucocorticoids; 50-02-2/Dexamethasone
Comment In:
Pediatrics. 2000 Oct;106(4):864   [PMID:  11183177 ]

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

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