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NCT01356147 · ClinicalTrials.gov registry record · Phase 4
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
A Phase 4 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01356147: Completed Phase 4 study, sponsored by Georgetown University.
NCT01356147 is a Phase 4 study that has completed, run by Georgetown University. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356147, a Phase 4 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation
Interventions
- DRUG Placebo
- DRUG Dornase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-05 |
| Est. Completion | 2017-04-30 |
| Phase | Phase 4 |
What the finished NCT01356147 record still lists
NCT01356147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01356147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01356147 about?
NCT01356147 is a clinical study titled "Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)". 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 ...
What is the current status of trial NCT01356147?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2011-05. Estimated completion is 2017-04-30.
What interventions are being tested in trial NCT01356147?
The interventions under investigation include: Placebo (DRUG), Dornase alfa (DRUG).
Who is sponsoring clinical trial NCT01356147?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01356147's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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