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| Sponsor: | China Medical University, China |
|---|---|
| Collaborators: |
National Taiwan University Hospital Taipei Medical University Hospital Cathay General Hospital Chang Gung Memorial Hospital |
| Information provided by: | China Medical University, China |
| ClinicalTrials.gov Identifier: | NCT00883532 |
Purpose
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.
The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome Chronic Lung Disease of Prematurity |
Drug: budesonide Drug: surfactant and air (placebo) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen |
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
budesonide: Experimental
The treatment group will receive surfactant and budesonide.
|
Drug: budesonide
budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
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surfactant and air: Placebo Comparator
The placebo group will receive surfactant and air as control.
|
Drug: surfactant and air (placebo)
receive surfactant and air as control through endotracheal route
|
After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 < 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.
The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.
Eligibility| Ages Eligible for Study: | up to 4 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tsu F Yeh, M.D. | 886-4-2203-4150 | tfyeh@mail.ncku.edu.tw |
| Contact: Yu C Pan, BS | 886-4-2203-4150 | yuchenpanpan@yahoo.com.tw |
| China, Taiwan | |
| China Medical University | Recruiting |
| Taichung, Taiwan, China | |
| Contact: Tsu F Yeh, M.D. 886-4-2203-4150 tfyeh@mail.ncku.edu.tw | |
| Contact: Yu C Pan, BS 886-4-2203-4150 yuchenpanpan@yahoo.com.tw | |
| Principal Investigator: Tsu F Yeh, M.D. | |
| Principal Investigator: | Tsu F Yeh, M.D. | China Medical university |
More Information
| Responsible Party: | College of medicine, china medical university,Taiwan ( Tsu F. Yeh/ Chair professor of Pediatrics ) |
| Study ID Numbers: | Yeh 2009 (CMU), NHRI |
| Study First Received: | April 15, 2009 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00883532 History of Changes |
| Health Authority: | China: Ethics Committee |
|
Preterm infant Respiratory distress syndrome chronic lung disease budesonide surfactant |
|
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 Infant, Premature, Diseases Hormones Glucocorticoids |
Pharmacologic Actions Bronchopulmonary Dysplasia Pathologic Processes Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Syndrome Infant, Newborn, Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Surfactants |
