Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia

Tsu F Yeh, Chung M Chen, Shou Y Wu, Zahid Husan, Tsai C Li, Wu S Hsieh, Chang H Tsai, Hung C Lin

Research output: Contribution to journalArticle

87 Citations (Scopus)

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, ≥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 www.clinicaltrials.gov (NCT-00883532).

Original languageEnglish
Pages (from-to)86-95
Number of pages10
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume193
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

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Budesonide
Bronchopulmonary Dysplasia
Surface-Active Agents
Very Low Birth Weight Infant
Interleukin-8
Artificial Respiration
Incidence
Clinical Trials
Confidence Intervals
Oxygen
Numbers Needed To Treat
Interleukins
Taiwan
Interleukin-1
Premature Infants
Glucocorticoids
Interleukin-6
Pneumonia
Odds Ratio
Parturition

Keywords

  • Bronchopulmonary Dysplasia
  • Budesonide
  • Drug Therapy, Combination
  • Female
  • Humans
  • Infant, Very Low Birth Weight
  • Intubation, Intratracheal
  • Male
  • Pulmonary Surfactants
  • Respiration, Artificial
  • Respiratory Distress Syndrome, Newborn
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

Cite this

Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. / Yeh, Tsu F; Chen, Chung M; Wu, Shou Y; Husan, Zahid; Li, Tsai C; Hsieh, Wu S; Tsai, Chang H; Lin, Hung C.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 193, No. 1, 01.01.2016, p. 86-95.

Research output: Contribution to journalArticle

Yeh, Tsu F ; Chen, Chung M ; Wu, Shou Y ; Husan, Zahid ; Li, Tsai C ; Hsieh, Wu S ; Tsai, Chang H ; Lin, Hung C. / Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. In: American Journal of Respiratory and Critical Care Medicine. 2016 ; Vol. 193, No. 1. pp. 86-95.
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AB - 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 www.clinicaltrials.gov (NCT-00883532).

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KW - Infant, Very Low Birth Weight

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KW - Male

KW - Pulmonary Surfactants

KW - Respiration, Artificial

KW - Respiratory Distress Syndrome, Newborn

KW - Journal Article

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