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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Georgetown University
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Melissa Scala, Georgetown University
ClinicalTrials.gov Identifier:
NCT01356147
First received: March 29, 2011
Last updated: August 18, 2014
Last verified: August 2012
  Purpose

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 Intervention Phase
Pulmonary Infections
Drug: Dornase alfa
Drug: Sham therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Percent Reduction in Oxygen Requirement from baseline [ Time Frame: First week of treatment or extubation ] [ Designated as safety issue: No ]
    Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of days on Ventilator Support [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham placebo
No therapy will be given to placebo arm.
Drug: Sham therapy
No therapy will be given to placebo arm
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

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356147

Contacts
Contact: Melissa Scala, MD 202-444-7137 Melissa.L.Scala@gunet.georgetown.edu

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Melissa Scala, MD    202-444-7137      
Georgetown University Hospital NICU Not yet recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Melissa Scala, MD         
Sponsors and Collaborators
Georgetown University
Genentech, Inc.
  More Information

No publications provided

Responsible Party: Melissa Scala, Fellow, Department of Neonatology, Georgetown University
ClinicalTrials.gov Identifier: NCT01356147     History of Changes
Other Study ID Numbers: Z4962s
Study First Received: March 29, 2011
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
ventilator associated pulmonary infections

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 20, 2014