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

Pulmonary Infections Clinical Trial

— PVAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356147
• Other study ID #: Z4962s
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: April 30, 2017

Study information

• Verified date: July 2018
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 30, 2017
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pulmonary Infections

Intervention

Drug:
• Dornase alfa
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
• Placebo
No therapy will be given to placebo arm

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Georgetown University Hospital NICU	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Reduction in Oxygen Requirement From Baseline	Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation	First week of treatment or extubation
Secondary	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	During first week of treatment or until extubation whichever is earlier
Secondary	Number of Infants Requiring Ventilator Support	number of infants extubated during treatment/sham	7 days