Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146497
Status:
TERMINATED
Last Update Posted:
2006-06-27
First Post:
2005-09-04
Brief Title:
Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 SB group received surfactant Survanta Abbott Laboratories North Chicago IL 100 mg or 4 mLkgdose and Budesonide Pulmicort AstraZeneca Pty Ltd Australia 05 mg or 1mLkgdose while those in the control group S group received surfactant Survanta Abbott 100 mgkgdose and saline 1mLkg
Detailed Description:
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 ventilationThe investigators 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 SB 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 SB treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None