Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia

Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.


Rationale: 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.

Objectives: To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD.

Methods: 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.

Measurements and main results: 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.

Conclusions: 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 (NCT-00883532).

Trial registration: NCT00883532.

Keywords: bronchopulmonary dysplasia; budesonide; respiratory distress syndrome; surfactant; very-low-birth-weight infants.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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


  • Pulmonary Surfactants
  • Budesonide

Associated data