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Previous Volume 344:95-101 January 11, 2001 Number 2 Next

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ABSTRACT

Background Early administration of high doses of dexamethasone may reduce the risk of chronic lung disease in premature infants but can cause complications. Whether moderate doses would be as effective but safer is not known.

Methods We randomly assigned 220 infants with a birth weight of 501 to 1000 g who were treated with mechanical ventilation within 12 hours after birth to receive dexamethasone or placebo with either routine ventilatory support or permissive hypercapnia. The dexamethasone was administered within 24 hours after birth at a dose of 0.15 mg per kilogram of body weight per day for three days, followed by a tapering of the dose over a period of seven days. The primary outcome was death or chronic lung disease at 36 weeks' postmenstrual age.

Results The relative risk of death or chronic lung disease in the dexamethasone-treated infants, as compared with those who received placebo, was 0.9 (95 percent confidence interval, 0.8 to 1.1). Since the effect of dexamethasone treatment did not vary according to the ventilatory approach, the two dexamethasone groups and the two placebo groups were combined. The infants in the dexamethasone group were less likely than those in the placebo group to be receiving oxygen supplementation 28 days after birth (P=0.004) or open-label dexamethasone (P=0.01), were more likely to have hypertension (P<0.001), and were more likely to be receiving insulin treatment for hyperglycemia (P=0.02). During the first 14 days, spontaneous gastrointestinal perforation occurred in a larger proportion of infants in the dexamethasone group (13 percent, vs. 4 percent in the placebo group; P=0.02). The dexamethasone-treated infants had a lower weight (P=0.02) and a smaller head circumference (P=0.04) at 36 weeks' postmenstrual age.

Conclusions In preterm infants, early administration of dexamethasone at a moderate dose has no effect on death or chronic lung disease and is associated with gastrointestinal perforation and decreased growth.

Source Information

From Brigham and Women's Hospital, Boston (A.R.S.); the University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Texas at Houston, Houston (J.E.T.); the University of New Mexico, Albuquerque (L.-A.P.); the National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W.); Wayne State University, Detroit (S. Shankaran); the University of Cincinnati, Cincinnati (E.F.D.); Women and Infant's Hospital, Providence, R.I. (W.O.); the University of Miami, Miami (C.R.B.); Research Triangle Institute, Research Triangle Park, N.C. (S. Saha, W.K.P.); and Emory University, Atlanta (B.J.S.). Other authors were Avroy A. Fanaroff, M.B., B.Ch., Case Western Reserve University, Cleveland; Richard A. Ehrenkranz, M.D., Yale University, New Haven, Conn.; Sheldon B. Korones, M.D., University of Tennessee at Memphis, Memphis; and David K. Stevenson, M.D., Stanford University, Stanford, Calif.

Address reprint requests to Dr. Stark at Newborn Medicine, CWN-6, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at astark{at}uptodate.com.

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