| A multicenter trial of two dexamethasone regimens in ventilator-dependent premature infants. | |
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MedLine Citation:
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PMID: 9545359 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 52.4 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 > or =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 ages. |
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Authors:
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L A Papile; J E Tyson; B J Stoll; L L Wright; E F Donovan; C R Bauer; H Krause-Steinrauf; J Verter; S B Korones; J A Lemons; A A Fanaroff; D K Stevenson |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: The New England journal of medicine Volume: 338 ISSN: 0028-4793 ISO Abbreviation: N. Engl. J. Med. Publication Date: 1998 Apr |
Date Detail:
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Created Date: 1998-04-16 Completed Date: 1998-04-16 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1112-8 Citation Subset: AIM; IM |
Affiliation:
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University of New Mexico, Albuquerque, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Age Factors Bacteremia / chemically induced Chronic Disease Cross Infection / chemically induced Dexamethasone / administration & dosage*, adverse effects Double-Blind Method Drug Administration Schedule Female Glucocorticoids / administration & dosage*, adverse effects Humans Hyperglycemia / chemically induced Infant Infant, Newborn Infant, Premature Infant, Premature, Diseases / prevention & control* Infant, Very Low Birth Weight* Lung Diseases / prevention & control* Male Respiration, Artificial* Time Factors Ventilator Weaning |
| Grant Support | |
ID/Acronym/Agency:
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U10 HD21373/HD/NICHD NIH HHS; U10 HD27851/HD/NICHD NIH HHS; U10 HD27881/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Glucocorticoids; 50-02-2/Dexamethasone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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