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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
No therapy will be given to placebo arm
Georgetown University Hospital NICU
Washington D.C., District of Columbia, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Percent Reduction in Oxygen Requirement From Baseline
Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation
Time frame: First week of treatment or extubation
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
Time frame: During first week of treatment or until extubation whichever is earlier
Number of Infants Requiring Ventilator Support
number of infants extubated during treatment/sham
Time frame: 7 days
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