Prevention of Chronic Lung Disease (CLD) in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT00883532|
Recruitment Status : Unknown
Verified April 2009 by China Medical University, China.
Recruitment status was: Recruiting
First Posted : April 17, 2009
Last Update Posted : August 8, 2012
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 or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome Chronic Lung Disease of Prematurity||Drug: budesonide Drug: surfactant and air (placebo)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||April 2013|
The treatment group will receive surfactant and budesonide.
budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
Other Name: pulmicort
Placebo Comparator: surfactant and air
The placebo group will receive surfactant and air as control.
Drug: surfactant and air (placebo)
receive surfactant and air as control through endotracheal route
Other Name: survanta
- Chronic lung disease morbidity among the survival [ Time Frame: 36 postconceptional weeks ]
- Neurodevelopment [ Time Frame: 2 years of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883532
|Contact: Tsu F Yeh, M.D.||firstname.lastname@example.org|
|Contact: Yu C Pan, BSemail@example.com|
|Principal Investigator:||Tsu F Yeh, M.D.||China Medical University, China|