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Original Article
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Volume 338:1112-1119 April 16, 1998 Number 16
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A Multicenter Trial of Two Dexamethasone Regimens in Ventilator-Dependent Premature Infants
Lu-Ann Papile, M.D., Jon E. Tyson, M.D., Barbara J. Stoll, M.D., Linda L. Wright, M.D., Edward F. Donovan, M.D., Charles R. Bauer, M.D., Heidi Krause-Steinrauf, M.S., Joel Verter, Ph.D., Sheldon B. Korones, M.D., James A. Lemons, M.D., Avroy A. Fanaroff, M.B., B.Ch., David K. Stevenson, M.D., William Oh, Richard A. Ehrenkranz, and Seetha Shankaran

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ABSTRACT

Background Ventilator-dependent premature infants are often treated with dexamethasone. However, the optimal timing of therapy is unknown.

Methods We compared the benefits and hazards of initiating dexamethasone therapy at two weeks of age and at four weeks of age in 371 ventilator-dependent very-low-birth-weight infants (501 to 1500 g) who had respiratory-index scores (mean airway pressure x the fraction of inspired oxygen) of >2.4 at two weeks of age. One hundred eighty-two infants received dexamethasone for two weeks followed by placebo for two weeks, and 189 infants received placebo for two weeks followed by either dexamethasone (those with a respiratory-index score of >2.4 on treatment day 14) or additional placebo for two weeks. Dexamethasone was given at a dose of 0.25 mg per kilogram of body weight twice daily intravenously or orally for five days, and the dose was then tapered.

Results The median time to ventilator independence was 36 days in the dexamethasone–placebo group and 37 days in the placebo–dexamethasone group. The incidences of chronic lung disease (defined as the need for oxygen supplementation at 36 weeks' postconceptional age) were 66 percent and 67 percent, respectively. Dexamethasone was associated with an increased incidence of nosocomial bacteremia (relative risk, 1.5; 95 percent confidence interval, 1.1 to 2.1) and hyperglycemia (relative risk, 1.9; 95 percent confidence interval, 1.2 to 3.0) in the dexamethasone–placebo group, elevated blood pressure (relative risk, 2.9; 95 percent confidence interval, 1.2 to 6.9) in the placebo–dexamethasone group, and diminished weight gain and head growth (P<0.001) in both groups.

Conclusions Treatment of ventilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four weeks of age.


Source Information

From the University of New Mexico, Albuquerque (L.-A.P.); the University of Texas Southwestern Medical Center, Dallas (J.E.T.); Emory University, Atlanta (B.J.S.); the National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W.); the University of Cincinnati, Cincinnati (E.F.D.); the University of Miami, Miami (C.R.B.); the George Washington University Biostatistics Center, Rockville, Md. (H.K.-S., J.V.); the University of Tennessee at Memphis, Memphis (S.B.K.); Indiana University, Indianapolis (J.A.L.); Case Western Reserve University, Cleveland (A.A.F.); and Stanford University, Stanford, Calif. (D.K.S.). Other authors were William Oh, M.D. (Women and Infants Hospital, Providence, R.I.); Richard A. Ehrenkranz, M.D. (Yale University, New Haven, Conn.); and Seetha Shankaran, M.D. (Wayne State University, Detroit).

Address reprint requests to Dr. Papile at the University of New Mexico Health Sciences Center, UNMH ACC 3 West, Department of Pediatrics, Albuquerque, NM 87131.

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