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

This study is currently recruiting participants.

Verified August 2012 by Georgetown University

Sponsor:

Collaborator:

Genentech

Information provided by (Responsible Party):

Melissa Scala, Georgetown University

ClinicalTrials.gov Identifier:

NCT01356147

First received: March 29, 2011

Last updated: August 22, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2011

Last Updated Date

August 22, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01356147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Infections

Intervention ^ICMJE

Drug: Dornase alfa
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Other Name: Pulmozyme
Drug: Sham therapy
No therapy will be given to placebo arm

Study Arm (s)

Sham Comparator: Sham placebo
No therapy will be given to placebo arm.

Intervention: Drug: Sham therapy
Active Comparator: Dornase alfa
Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Intervention: Drug: Dornase alfa

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 4 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Melissa Scala, MD

202-444-7137

Melissa.L.Scala@gunet.georgetown.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01356147

Other Study ID Numbers ^ICMJE

Z4962s

Has Data Monitoring Committee

Responsible Party

Melissa Scala, Georgetown University

Study Sponsor ^ICMJE

Georgetown University

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Not Provided

Information Provided By

Georgetown University

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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