Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants

Ann R. Stark, Waldemar A. Carlo, Jon E. Tyson, Lu Ann Papile, Linda L. Wright, Seetha Shankaran, Edward F. Donovan, William Oh, Charles R Bauer, Shampa Saha, W. Kenneth Poole, Barbara J. Stoll, Avroy A. Fanaroff, Richard A. Ehrenkranz, Sheldon B. Korones, David K. Stevenson

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)95-101
Number of pages7
JournalNew England Journal of Medicine
Volume344
Issue number2
DOIs
StatePublished - Jan 11 2001

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Extremely Low Birth Weight Infant
Dexamethasone
Placebos
Lung Diseases
Chronic Disease
Therapeutics
Parturition
Premature Infants
Hypercapnia
Artificial Respiration
Birth Weight
Hyperglycemia

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Stark, A. R., Carlo, W. A., Tyson, J. E., Papile, L. A., Wright, L. L., Shankaran, S., ... Stevenson, D. K. (2001). Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants. New England Journal of Medicine, 344(2), 95-101. https://doi.org/10.1056/NEJM200101113440203

Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants. / Stark, Ann R.; Carlo, Waldemar A.; Tyson, Jon E.; Papile, Lu Ann; Wright, Linda L.; Shankaran, Seetha; Donovan, Edward F.; Oh, William; Bauer, Charles R; Saha, Shampa; Poole, W. Kenneth; Stoll, Barbara J.; Fanaroff, Avroy A.; Ehrenkranz, Richard A.; Korones, Sheldon B.; Stevenson, David K.

In: New England Journal of Medicine, Vol. 344, No. 2, 11.01.2001, p. 95-101.

Research output: Contribution to journalArticle

Stark, AR, Carlo, WA, Tyson, JE, Papile, LA, Wright, LL, Shankaran, S, Donovan, EF, Oh, W, Bauer, CR, Saha, S, Poole, WK, Stoll, BJ, Fanaroff, AA, Ehrenkranz, RA, Korones, SB & Stevenson, DK 2001, 'Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants', New England Journal of Medicine, vol. 344, no. 2, pp. 95-101. https://doi.org/10.1056/NEJM200101113440203
Stark, Ann R. ; Carlo, Waldemar A. ; Tyson, Jon E. ; Papile, Lu Ann ; Wright, Linda L. ; Shankaran, Seetha ; Donovan, Edward F. ; Oh, William ; Bauer, Charles R ; Saha, Shampa ; Poole, W. Kenneth ; Stoll, Barbara J. ; Fanaroff, Avroy A. ; Ehrenkranz, Richard A. ; Korones, Sheldon B. ; Stevenson, David K. / Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants. In: New England Journal of Medicine. 2001 ; Vol. 344, No. 2. pp. 95-101.
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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.",
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AU - Carlo, Waldemar A.

AU - Tyson, Jon E.

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AU - Wright, Linda L.

AU - Shankaran, Seetha

AU - Donovan, Edward F.

AU - Oh, William

AU - Bauer, Charles R

AU - Saha, Shampa

AU - Poole, W. Kenneth

AU - Stoll, Barbara J.

AU - Fanaroff, Avroy A.

AU - Ehrenkranz, Richard A.

AU - Korones, Sheldon B.

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N2 - 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.

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