Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia

• Published in: American journal of respiratory and critical care medicine Vol. 193; no. 1; pp. 86 - 95
• Main Authors: Yeh, Tsu F, Chen, Chung M, Wu, Shou Y, Husan, Zahid, Li, Tsai C, Hsieh, Wu S, Tsai, Chang H, Lin, Hung C
• Format: Journal Article
• Language: English
• Published: United States American Thoracic Society 01.01.2016
• Subjects: Bronchopulmonary Dysplasia - prevention & control; Budesonide - administration & dosage; Budesonide - therapeutic use; Drug Therapy, Combination; Female; Humans; Infant, Very Low Birth Weight; Intubation, Intratracheal; Male; Pulmonary Surfactants - administration & dosage; Pulmonary Surfactants - therapeutic use; Respiration, Artificial - adverse effects; Respiration, Artificial - methods; Respiratory Distress Syndrome, Newborn - mortality; Respiratory Distress Syndrome, Newborn - therapy; budesonide; respiratory distress syndrome; very-low-birth-weight infants; bronchopulmonary dysplasia; surfactant
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.201505-0861oc

Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD. To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD. A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ≥50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control infants received surfactant only (100 mg/kg), until each infant required inspired O2 at less than 30% or was extubated. The intervention group had a significantly lower incidence of BPD or death (55 of 131 [42.0%] vs. 89 of 134 [66%]; risk ratio, 0.58; 95% confidence interval, 0.44-0.77; P < 0.001; number needed to treat, 4.1; 95% confidence interval, 2.8-7.8). The intervention group required significantly fewer doses of surfactant than did the control group. The intervention group had significantly lower interleukin levels (IL-1, IL-6, IL-8) in tracheal aspirates at 12 hours and lower IL-8 at 3-5 and 7-8 days. 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).