PEDIATRICS Vol. 104 No. 1 January 1999, pp. 22-27
Randomized Placebo-controlled Trial of a 42-Day Tapering Course of Dexamethasone to Reduce the Duration of Ventilator Dependency in Very Low Birth Weight Infants
Received Apr 21, 1998; accepted Nov 19, 1998.
,
From the Departments of * Pediatrics, Radiology, and
§ Surgery (Ophthalmology), Wake Forest University School of Medicine,
Winston-Salem, North Carolina.
Objective. To assess the effect on duration of ventilator dependency of a 42-day tapering course of dexamethasone in very low birth weight neonates.
Methods. Infants (N = 118) were
assigned randomly, within birth weight/gender strata, to treatment with
either a 42-day tapering course of dexamethasone or an equal volume of
saline as placebo. Entry criteria were 1) birth weight <1501
g; 2) age between 15 and 25 days; 3) <10% decrease in ventilator
settings for 24 hours and FIO2 
0.3; 4)
absence of patent ductus arteriosus, sepsis, major congenital
malformation, congenital heart disease; and 5) no evidence of maternal
HIV or hepatitis B infection. The dosage schedule was 0.25 mg/kg bid
for 3 days, then 0.15 mg/kg bid for 3 days, then a 10% reduction in
the dose every 3 days until a dose of 0.1 mg/kg had been given for 3 days, from which time a dose of 0.1 mg/kg qod was continued until 42 days after entry. The primary endpoint was the number of days on
assisted ventilation after study entry. Secondary outcomes of interest
included days on supplemental oxygen, days of hospitalization, and
potential adverse effects, such as infection, gastrointestinal
bleeding, left ventricular hypertrophy, and severe retinopathy of
prematurity.
Results. Infants in the dexamethasone- and placebo-treated
groups were similar in terms of baseline attributes, including birth
weight, gestational age, gender, race, and ventilator settings at
entry. Infants treated with dexamethasone were on assisted ventilation and supplemental oxygen for fewer days after study entry (median days
on ventilator, 5th and 95th percentiles, 13 [1-64] vs 25 [6-104]; days on oxygen, 59 [6-247] vs 100 [11-346]).
No differences were found in risk of death, infection, or severe
retinopathy. In subgroup analyses, the association of dexamethasone
with more rapid weaning from the ventilator was weaker among infants
enrolled before the 16th day of life, infants with chest radiographs
showing cystic changes and/or hyperinflation, and infants requiring an FIO2 0.7 or a peak inspiratory
pressure 19 at study entry.
Conclusions. A 42-day tapering course of dexamethasone decreases the duration of ventilator and oxygen dependency in very low birth weight infants and is not associated with an increased risk of short-term adverse effects. Key words: bronchopulmonary dysplasia, dexamethasone, chronic lung disease, very low birth weight, randomized controlled trials.
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