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PEDIATRICS Vol. 104 No. 1 July 1999, pp. 15-21

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

Received Apr 21, 1998; accepted Nov 19, 1998.

T. Michael O'Shea*, Jamanadas M. Kothadia*, Kurt L. Klinepeter*, Donald J. Goldstein*, Barbara G. Jackson*, R. Grey Weaver, and IIIddager ; and Robert G. Dillard*

From the Departments of * Pediatrics and Dagger  Surgery (Ophthalmology), Wake Forest University School of Medicine, Winston-Salem, North Carolina.

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.  Key words:  bronchopulmonary dysplasia, dexamethasone, chronic lung disease, very low birth weight, randomized controlled trials, developmental outcome, cerebral palsy.


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Pediatrics, January 1, 2001; 107(1): 105 - 112.
[Abstract] [Full Text]

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 Arch. Dis. Child. Fetal Neonatal Ed.Home page
E S Shinwell, M Karplus, D Reich, Z Weintraub, S Blazer, D Bader, S Yurman, T Dolfin, A Kogan, S Dollberg, et al.
Early postnatal dexamethasone treatment and increased incidence of cerebral palsy
Arch. Dis. Child. Fetal Neonatal Ed., November 1, 2000; 83(3): 177F - 181.
[Abstract] [Full Text]

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 Reproductive SciencesHome page
H. H. Kay, I. M. Bird, C. L. Coe, and D. J. Dudley
Antenatal Steroid Treatment and Adverse Fetal Effects: What Is the Evidence?
Reproductive Sciences, September 1, 2000; 7(5): 269 - 278.
[Abstract] [PDF]

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 Arch. Dis. Child. Fetal Neonatal Ed.Home page
A. Whitelaw and M. Thoresen
Antenatal steroids and the developing brain
Arch. Dis. Child. Fetal Neonatal Ed., September 1, 2000; 83(2): 154F - 157.
[Abstract] [Full Text]

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 Arch Pediatr Adolesc MedHome page
M. Hack, D. Wilson-Costello, H. Friedman, G. H. Taylor, M. Schluchter, and A. A. Fanaroff
Neurodevelopment and Predictors of Outcomes of Children With Birth Weights of Less Than 1000 g: 1992-1995
Arch Pediatr Adolesc Med, July 1, 2000; 154(7): 725 - 731.
[Abstract] [Full Text] [PDF]

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 Evid. Based Nurs.Home page
D. F. Askin
A 42 day tapering course of dexamethasone reduced duration of assisted ventilation in very low birthweight infants, but increased risk of cerebral palsy at age 1 year
Evid. Based Nurs., April 1, 2000; 3(2): 41 - 41.
[Full Text]

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 PediatricsHome page
R. A. Sinkin, H. S. Dweck, M. J. Horgan, K. J. Gallaher, C. Cox, W. M. Maniscalco, P. R. Chess, C. T. D'Angio, R. Guillet, J. W. Kendig, et al.
Early Dexamethasone---Attempting To Prevent Chronic Lung Disease
Pediatrics, March 1, 2000; 105(3): 542 - 548.
[Abstract] [Full Text]