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

Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia.

Author information

1
1 Maternal Child Health Research Center, College of Medicine, and.
2
2 Department of Pediatrics, Children's Hospital, and.
3
4 Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
4
3 Department of Pediatrics, Taipei Medical University Hospital, Taipei, Taiwan.
5
5 Division of Neonatology, John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois.
6
6 Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung, Taiwan.
7
7 Department of Healthcare Administration, College of Health Science, and.
8
8 Department of Pediatrics, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
9
9 Department of Biotechnology, Asian University, Taichung, Taiwan; and.

Abstract

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, ā‰„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; Pā€‰<ā€‰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).

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00883532.

KEYWORDS:

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

PMID:
26351971
DOI:
10.1164/rccm.201505-0861OC
[Indexed for MEDLINE]

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