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

Primary Purpose

Pulmonary Infections

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dornase alfa

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Infections focused on measuring ventilator associated pulmonary infections

Eligibility Criteria

7 Days - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Georgetown University Hospital NICU
Georgetown University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham placebo

Dornase alfa

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Percent Reduction in Oxygen Requirement From Baseline

Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation

Secondary Outcome Measures

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

Number of Infants Requiring Ventilator Support

number of infants extubated during treatment/sham

Full Information

NCT ID

NCT01356147

First Posted

March 29, 2011

Last Updated

July 31, 2018

Sponsor

Georgetown University

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01356147

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Georgetown University

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Infections

Keywords

ventilator associated pulmonary infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham placebo

Arm Type

Sham Comparator

Arm Description

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.

Arm Title

Dornase alfa

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dornase alfa

Other Intervention Name(s)

Pulmozyme

Intervention Description

2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sham therapy

Intervention Description

No therapy will be given to placebo arm

Primary Outcome Measure Information:

Title

Percent Reduction in Oxygen Requirement From Baseline

Description

Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation

Time Frame

First week of treatment or extubation

Secondary Outcome Measure Information:

Title

Elimination of White Blood Cells and Bacteria From Tracheal Aspirate

Description

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

Time Frame

During first week of treatment or until extubation whichever is earlier

Title

Number of Infants Requiring Ventilator Support

Description

number of infants extubated during treatment/sham

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Days

Maximum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Georgetown University Hospital NICU

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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