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

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ClinicalTrials.gov Identifier: NCT01356147
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : February 8, 2017
Last Update Posted : June 14, 2017
Genentech, Inc.
Information provided by (Responsible Party):
Melissa Scala, Georgetown University

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Infections Drug: Dornase alfa Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Primary Completion Date : January 2015
Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham placebo
No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Drug: Placebo
No therapy will be given to placebo arm
Other Name: Sham therapy
Active Comparator: Dornase alfa
Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Drug: Dornase alfa
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Other Name: Pulmozyme

Primary Outcome Measures :
  1. Percent Reduction in Oxygen Requirement From Baseline [ Time Frame: First week of treatment or extubation ]
    Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation

Secondary Outcome Measures :
  1. 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 ]
  2. Number of Days on Ventilator Support [ Time Frame: 7 days ]

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356147

United States, District of Columbia
Georgetown University Hospital NICU
Washington, D.C., District of Columbia, United States, 20007
Georgetown University Hospital
Washington, D.C., District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Genentech, Inc.

Responsible Party: Melissa Scala, Assistant Professor of Pediatrics, Department of Neonatology, Georgetown University
ClinicalTrials.gov Identifier: NCT01356147     History of Changes
Other Study ID Numbers: Z4962s
First Posted: May 19, 2011    Key Record Dates
Results First Posted: February 8, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Melissa Scala, Georgetown University:
ventilator associated pulmonary infections

Additional relevant MeSH terms:
Communicable Diseases