In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect. Clinical trial registered with www.clinicaltrials.gov (NCT-00883532).
Severe bronchopulmonary dysplasia (BPD) is common disease, especially for the tiniest infants with gestational age <27 weeks whose mothers did not receive adequate antenatal steroid prophylaxis. Systemic corticosteroids have been demonstrated to be effective in the prevention of BPD, but their adverse effects prevent routine use. The results of inhaled steroid therapy in intubated premature infants are disappointing. In a pilot study, infants in the treatment group who received early intratracheal instillation of budesonide by using surfactant as a vehicle required significantly less ventilator support during the first 2 weeks than infants in the control group. The combined outcome of deaths or BPD was significantly lower in the treatment group than in the control group. No clinically significant adverse effects from the treatment were observed during the study. The results are encouraging, and a large sample multicenter trial is warranted.
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