- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00146497
Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants
June 26, 2006 updated by: China Medical University Hospital
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan
- China Medical University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 hour to 1 day (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preterm infants with birth weight between 500-1500 gm
- Have severe radiographic RDS and require mechanical ventilation within 4 hours after birth
Exclusion Criteria:
- Presence of prenatal infection, congenital anomalies and lethal cardio-pulmonary status.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome variables are the levels of proinflammatory cytokines IL-6, IL-8 and TNF-α and anti-inflammatory cytokine IL-10.
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Secondary Outcome Measures
Outcome Measure |
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The secondary outcome is the clinical endpoint of survival free of oxygen dependence at 36 wks postmenstrual age.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Registration Dates
First Submitted
September 4, 2005
First Submitted That Met QC Criteria
September 4, 2005
First Posted (ESTIMATE)
September 7, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 27, 2006
Last Update Submitted That Met QC Criteria
June 26, 2006
Last Verified
June 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Lung Diseases
- Premature Birth
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
- Pulmonary Surfactants
Other Study ID Numbers
- DMR92-IRB-127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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