Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
China Medical University Hospital |
---|---|
Information provided by: | China Medical University Hospital |
ClinicalTrials.gov Identifier: | NCT00146497 |
Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline
(1mL/kg).
Condition | Intervention | Phase |
---|---|---|
Premature Infants Respiratory Distress Syndrome Chronic Lung Disease Bronchoalveolar Lavage Fluid Cytokines |
Drug: Budesonide-Surfactant |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | August 2004 |
Growing evidence suggests that early, postnatal pulmonary inflammation may play an important role in the development of chronic lung disease (CLD) in preterm infants on mechanical ventilation.The investigator's previous study demonstrated that interleukin-8 (IL-8), a marker of inflammation, in bronchoalveolar lavage (BAL) fluid increased by as early as 2 days of age in infants who subsequently developed CLD compared with infants who did not develop the disease. Thus for any therapy to be beneficial in preventing CLD, it should be started very early. Early postnatal use of intravenous dexamethasone therapy for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis which affected the immediate outcome and contributed significantly to mortality. It was shown that school age children who had received early postnatal dexamethasone therapy for the prevention of CLD showed a significant increase in incidence of neuromotor and cognitive delay.
Based on the results of these studies, early systemic dexamethasone therapy should not be recommended. Budesonide has high local anti-inflammatory activity and is one of the most extensively used inhaled glucocorticoids.
Budesonide decreases airway hyperresponsiveness and reduces the number of inflammatory cells and mediators present in the airways of patients with asthma. A previous study indicated that the addition of Budesonide to Survanta did not affect the surface tension. We proposed a randomized controlled trial to study whether early endotracheal instillation of Surfactant-Budesonide (S/B) mixture would reduce lung inflammation and improve pulmonary outcome. We will measure the cytokines levels in BAL fluid to evaluate the local anti-inflammatory effect of S/B treatment.
Ages Eligible for Study: | up to 1 Day |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DMR92-IRB-127 |
Study First Received: | September 4, 2005 |
Last Updated: | June 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00146497 History of Changes |
Health Authority: | Taiwan: Department of Health |
Respiratory distress syndrome (RDS) Premature infants Chronic lung disease (CLD) Bronchoalveolar lavage fluid (BALF) Cytokines |
Anti-Inflammatory Agents Hormone Antagonists Respiratory Distress Syndrome, Adult Respiration Disorders Acute Respiratory Distress Syndrome Budesonide Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Glucocorticoids Hormones Respiratory Tract Diseases Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Surfactants |
Anti-Inflammatory Agents Respiratory System Agents Disease Physiological Effects of Drugs Respiratory Distress Syndrome, Adult Respiration Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Hormones Glucocorticoids |
Pharmacologic Actions Pathologic Processes Respiratory Tract Diseases Autonomic Agents Lung Diseases Syndrome Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Surfactants |