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A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia
J J Cummings1, D B D'Eugenio, S J Gross
1Department of Pediatrics, State University of New York Health Science Center, Syracuse.
Insights
Dexamethasone therapy for 42 days significantly improved pulmonary and neurodevelopmental outcomes in very-low-birth-weight infants at high risk for bronchopulmonary dysplasia. Shorter treatment durations did not yield the same benefits, with no observed clinical complications.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Bronchopulmonary dysplasia (BPD) is a significant cause of morbidity in preterm infants.
- Early BPD diagnosis and management are crucial for improving infant outcomes.
- Corticosteroids, like dexamethasone, are explored for their potential to reduce BPD-related complications.
Purpose of the Study:
- To evaluate the efficacy of dexamethasone in reducing morbidity associated with bronchopulmonary dysplasia in preterm infants.
- To compare the outcomes of a 42-day dexamethasone course versus an 18-day course and placebo.
- To assess the impact of dexamethasone on mechanical ventilation weaning, oxygen dependence, and neurodevelopmental outcomes.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 36 preterm infants (birth weight ≤ 1250 g, gestational age ≤ 30 weeks) requiring oxygen and mechanical ventilation.
- Infants received either a 42-day course of dexamethasone (n=13), an 18-day course (n=12), or saline placebo (n=11).
- Dexamethasone dosage started at 0.5 mg/kg/day and was progressively reduced.
Main Results:
- The 42-day dexamethasone group weaned from mechanical ventilation significantly faster (median 29 days) than the 18-day group (73 days) and placebo (84 days).
- Similarly, the 42-day group showed faster weaning from supplemental oxygen (median 65 days) compared to the 18-day (190 days) and placebo (136 days) groups.
- Neurodevelopmental follow-up at 6 and 15 months showed better outcomes in the 42-day dexamethasone group (7/9 infants) compared to the 18-day group (2/9) and placebo (2/5).
Conclusions:
- A 42-day course of dexamethasone therapy significantly improves pulmonary and neurodevelopmental outcomes in very-low-birth-weight infants at high risk for BPD.
- The 18-day dexamethasone regimen did not show significant benefits over placebo for the studied outcomes.
- No clinical complications were observed with dexamethasone administration during the trial.
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.