Dexamethasone Therapy in VLBW Infants at Risk of CLD



Status:Completed
Conditions:Bronchitis, Women's Studies
Therapuetic Areas:Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:September 1992
End Date:April 1994

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Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD)

Infants who are on breathing support are often treated with steroids (dexamethasone);
however, the best timing of therapy is not known. This trial looked at the benefits and
hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in
premature infants.

Ventilator-dependent premature infants are often treated with dexamethasone. However, the
optimal timing of therapy is unknown. 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 grams) who had
respiratory-index scores (mean airway pressure x the fraction of inspired oxygen) of greater
than or equal 2.4 at two weeks of age. The primary outcome was the number of days from
randomization to extubation not requiring reintubation (extubation score or death). The
secondary outcomes were death before discharge from the hospital; the duration of assisted
ventilation, supplementary oxygen therapy and hospital stay; the incidence of chronic lung
disease (defined as the need for supplemental oxygen at 36 weeks postconceptional age by best
obstetrical estimate) and rates of morbidity and mortality from respiratory causes during the
first year. Additional secondary endpoints were hyperglycemia, hypertension, growth,
bacteremia, necrotizing enterocolitis and upper GI bleeding.

The sample size of 370 was based on a 0.60 probability that the extubation score of late
treatment was greater than early treatment, a 5% two-sided type 1 error, 85% power, and 10%
treatment noncompliance.

Infants were randomized to either receive dexamethasone for two weeks followed by saline
placebo for two weeks, or saline placebo for two weeks followed by either dexamethasone or
additional placebo for two weeks (if they still met entry criteria). 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 then tapered.

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 less than 0.001) in both groups. 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.

Inclusion criteria:

- 501 to 1500 grams

- 13 to 15 days old

- Respiratory-index score of greater than or equal to 2.4 that had been increasing or
minimally decreasing during the previous 48 hours or a score of greater than or equal
to 4.0 even if there had been improvement during the preceding 48 hours

Exclusion criteria:

- Received glucocorticoid treatment after birth

- Had evidence or suspicious signs of sepsis as judged by the treating physician

- Major congenital anomaly of the cardiovascular, pulmonary, or central nervous system
We found this trial at
13
sites
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Providence, RI
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Cincinnati, Ohio 45267
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Cincinnati, OH
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Cleveland, OH
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palo Alto, California 94304
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Washington, District of Columbia 20052
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