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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. The investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham placebo | Sham Comparator | No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. |
|
| Dornase alfa | Active Comparator | Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dornase alfa | Drug | 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Oxygen Requirement From Baseline | Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation | First week of treatment or extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of White Blood Cells and Bacteria From Tracheal Aspirate | Number of infants with Tracheal aspirate WBC present on review of smear at end of therapy Bacterial load judged on presence of positive or negative culture in Tracheal aspirate | During first week of treatment or until extubation whichever is earlier |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital NICU | Washington D.C. | District of Columbia | 20007 | United States | ||
| Georgetown University Hospital |
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No enrolled participants were excluded prior to assignment to groups
Medstar Georgetown University Hospita NICU patients recruited from May 2012 to november 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Placebo | No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. Placebo: No therapy will be given to placebo arm |
| FG001 | Dornase Alfa | Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Placebo | No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. Placebo: No therapy will be given to placebo arm |
| BG001 | Dornase Alfa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Reduction in Oxygen Requirement From Baseline | Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation | Posted | Mean | Full Range | percentage FiO2 | First week of treatment or extubation |
|
During 7 day period of drug or sham treatment then throughout NICU admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Placebo | No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. Placebo: No therapy will be given to placebo arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Scala | Stanford University School of Medicine/Division of Neonatology | 650-724-9653 | mscala@stanford.edu |
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| ID | Term |
|---|---|
| C568813 | dornase alfa |
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| Placebo | Drug | No therapy will be given to placebo arm |
|
|
| Number of Infants Requiring Ventilator Support |
number of infants extubated during treatment/sham |
| 7 days |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Elimination of White Blood Cells and Bacteria From Tracheal Aspirate | Number of infants with Tracheal aspirate WBC present on review of smear at end of therapy Bacterial load judged on presence of positive or negative culture in Tracheal aspirate | Posted | Number | participants | During first week of treatment or until extubation whichever is earlier |
|
|
|
| Secondary | Number of Infants Requiring Ventilator Support | number of infants extubated during treatment/sham | Posted | Number | participants | 7 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Dornase Alfa | Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation | 0 | 6 | 0 | 6 |
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