Overview

This trial is active, not recruiting.

Condition pulmonary infections
Treatments dornase alfa, sham therapy
Phase phase 4
Sponsor Georgetown University
Collaborator Genentech, Inc.
Start date May 2011
End date January 2015
Trial size 20 participants
Trial identifier NCT01356147, Z4962s

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
No therapy will be given to placebo arm.
sham therapy
No therapy will be given to placebo arm
(Active Comparator)
Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
dornase alfa Pulmozyme
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Primary Outcomes

Measure
Percent Reduction in Oxygen Requirement from baseline
time frame: First week of treatment or extubation

Secondary Outcomes

Measure
Reduction in White Blood Cell count and Bacterial load from Tracheal Aspirate
time frame: During first week of treatment or until extubation whichever is earlier
Number of days on Ventilator Support
time frame: 7 days

Eligibility Criteria

Male or female participants up to 4 months old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Georgetown University.