NCT01356147

Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 7 Days – 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Infections

Interventions

Type	Name	Description
DRUG	Dornase alfa	2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
DRUG	Placebo	No therapy will be given to placebo arm

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-01-01
• Completion: 2017-04-30
• First posted: 2011-05-19
• Last updated: 2018-08-07
• Results posted: 2017-02-08

Locations

2 sites across 1 country: United States