A Controlled Trial of Dexamethasone in Preterm Infants at High Risk for Bronchopulmonary Dysplasia

Abstract

We evaluated the use of dexamethasone in preterm infants to decrease morbidity associated with bronchopulmonary dysplasia in a randomized, double-blind, placebo-controlled trial. Thirty-six preterm infants (birth weight, less than or equal to 1250 g and gestational age, less than or equal to 30 weeks) who were dependent on oxygen and mechanical ventilation at two weeks of age received a 42-day course of dexamethasone (n = 13), an 18-day course of dexamethasone (n = 12), or saline placebo (n = 11). The starting dose of dexamethasone was 0.5 mg per kilogram of body weight per day, and it was progressively lowered during the period of administration. Infants in the 42-day dexamethasone group, but not those in the 18-day group, were weaned from mechanical ventilation significantly faster than control infants (medians 29, 73, and 84 days, respectively; P less than 0.05), and from supplemental oxygen (medians 65, 190, and 136 days, respectively; P less than 0.05). No clinical complications of steroid administration were noted. Follow-up of all 23 survivors at 6 and 15 months of age showed good outcome (normal neurologic examinations and Bayley Developmental Indexes greater than or equal to 84) in 7 of the 9 infants in the 42-day dexamethasone group, but in only 2 of the 9 infants in the 18-day dexamethasone group and 2 of the 5 in the placebo group (P less than 0.05). We conclude that dexamethasone therapy for 42 days improves pulmonary and neurodevelopmental outcome in very-low-birth-weight infants at high risk for bronchopulmonary dysplasia.

Effect of Dexamethasone on Lymphocyte Subpopulations in Premature Infants with Bronchopulmonary Dysplasia

“…19 The 6-week treatment course started with 0.5 mg/kg per day intravenously for 3 days followed by 0.3 mg/kg per day for 4 days, with the dose decreasing by 10% every week for a total of 6 weeks of therapy. Blood samples for peripheral leukocyte count and lymphocyte subpopulations were obtained before starting dexamethasone therapy (day 0) and on days 3 and 10 of treatment.…”

A Randomized Trial of Inhaled Versus Intravenous Steroids in Ventilator-Dependent Preterm Infants

“…1,14 At 80% power, a sample size of 23 to 24 in each group would be sufficient to show that a difference in adverse effects of 30% or more was significant at p<0.05. To allow for some dropouts we therefore planned to enroll up to 27 infants in each of the three groups.…”

“…1 BPD is defined as either chronic lung disease requiring supplemental oxygen at 28 days of age or at 36 weeks postconceptional age that develops in premature neonates treated with oxygen and positive pressure mechanical ventilation for a primary lung disorder.…”

“…1,2 The inhaled route of delivery of steroids may maximize pulmonary effects while minimizing systemic effects as documented by the clinical success in delivering steroids through metered-dose inhalation to young asthmatic patients. 3,4 Initial studies examining inhaled steroids for the treatment of BPD in ventilator-dependent VLBW infants utilized both nebulized and metered-dose inhaled steroids, which appeared to be of some benefit for these infants.…”

Effects of Corticosteroids in Very Low Birth Weight Newborns Dependent on Mechanical Ventilation

“…7,9,10,12,13 However, we found a tendency for reduced mortality among newborns that received corticosteroids as described. 7,9,10,12,13 It is possible that because of the design of the study, in which the inclusion criterion was children dependent on mechanical ventilation between 10 and 14 days of life, newborns with severe pulmonary diseases may have been selected for inclusion, and consequently, evidence of favorable effects of corticosteroids upon the respiratory function in this selected group may not have become evident. However, it is important to note that the newborns included in the treated group had a tendency for a lower mortality rate, which indirectly could be suggesting that despite the severity of their conditions, certain benefits may have occurred.…”