Phase 4
N=11
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Pulmonary Infections
Bottom Line
View on ClinicalTrials.gov: NCT01356147 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Percent Reduction in Oxygen Requirement From Baseline — 5.4; 16.5 percentage FiO2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dornase alfa (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction in Oxygen Requirement From Baseline |
5.4; 16.5 | — |
| SECONDARY Elimination of White Blood Cells and Bacteria From Tracheal Aspirate |
1; 4 | — |
| SECONDARY Number of Infants Requiring Ventilator Support |
1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- infants less than 38 weeks gestation and over 7 days of age
- infants with a ventilator associated pulmonary infection, defined as intubated infants who have moderate to heavy White Blood Cells (WBCs) on tracheal aspirate, organisms on tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with infiltrate, consolidation or atelectasis, an increase in oxygen (FiO2) requirement and whom the clinical team decides to treat with systemic antibiotic therapy
Exclusion Criteria
- Extremely ill infants not expected to survive
- Critically ill infants requiring high frequency ventilation
- Infants with congenital pneumonia
- Infants with congenital malformations of the respiratory system (e.g. Congenital diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula) Cyanotic congenital heart disease, chromosomal abnormalities and infants with a positive newborn screen for cystic fibrosis
Data sourced from ClinicalTrials.gov (NCT01356147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.