Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia.
BACKGROUND
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.


OBJECTIVE
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.


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 www.clinicaltrials.gov (NCT-00883532).
1 Maternal Child Health Research Center, College of Medicine, and.|2 Department of Pediatrics, Children's Hospital, and.
Tsu F
TF
Yeh
1 Maternal Child Health Research Center, College of Medicine, and.|4 Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.|3 Department of Pediatrics, Taipei Medical University Hospital, Taipei, Taiwan.
Chung M
CM
Chen
5 Division of Neonatology, John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois.
Shou Y
SY
Wu
5 Division of Neonatology, John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois.
Zahid
Z
Husan
6 Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung, Taiwan.|7 Department of Healthcare Administration, College of Health Science, and.
Tsai C
TC
Li
8 Department of Pediatrics, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Wu S
WS
Hsieh
2 Department of Pediatrics, Children's Hospital, and.|9 Department of Biotechnology, Asian University, Taichung, Taiwan; and.
Chang H
CH
Tsai
2 Department of Pediatrics, Children's Hospital, and.
Hung C
HC
Lin
D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019102:Infant, Very Low Birth Weight; D007442:Intubation, Intratracheal; D008297:Male; D011663:Pulmonary Surfactants / Q000008:administration & dosage / Q000627:therapeutic use*; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods; D012127:Respiratory Distress Syndrome, Newborn / Q000401:mortality / Q000628:therapy
D011663:Pulmonary Surfactants; D019819:Budesonide
bronchopulmonary dysplasia; budesonide; respiratory distress syndrome; surfactant; very-low-birth-weight infants