CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Dornase alfa +1 moredrug
Likely dose
Dornase alfa 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01356147
NCT01356147Phase 4Completed
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Pilot Study of Dornase Alfa (Pulmozyme) Therapy for Acquired Ventilator Associated Infection in Preterm and Late Preterm Infants in the Neonatal Intensive Care Unit

Georgetown University·interventional·Posted May 19, 2011·Updated Aug 7, 2018

In Brief

A Phase 4 clinical trial evaluating Dornase alfa and Placebo for Pulmonary Infections. Completed, enrolled 11 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Infections
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2011
Enrollment StartMay 1, 2011
Primary CompletionJan 1, 2015
Study CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.1 years ago

Interventions

Dornase alfadrug

2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Placebodrug

No therapy will be given to placebo arm