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

• ClinicalTrials.gov Identifier: NCT01356147
• Recruitment Status: Completed
• First Posted: May 19, 2011
• Results First Posted: February 8, 2017
• Last Update Posted: August 7, 2018
• Sponsor: Georgetown University
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): Melissa Scala, Georgetown University

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.

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

Study Design

• 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
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: April 30, 2017

Arms and Interventions

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

Outcome Measures

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. Elimination of White Blood Cells and Bacteria From Tracheal Aspirate [ Time Frame: During first week of treatment or until extubation whichever is earlier ]
   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
2. Number of Infants Requiring Ventilator Support [ Time Frame: 7 days ]
   number of infants extubated during treatment/sham

Eligibility Criteria

• Ages Eligible for Study: up to 4 Months (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, District of Columbia

Georgetown University Hospital NICU

Washington, District of Columbia, United States, 20007

Georgetown University Hospital

Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

Georgetown University

Genentech, Inc.

More Information

• Responsible Party: Melissa Scala, Assistant Professor of Pediatrics, Department of Neonatology, Georgetown University
• ClinicalTrials.gov Identifier: NCT01356147
• Other Study ID Numbers: Z4962s
• First Posted: May 19, 2011
• Results First Posted: February 8, 2017
• Last Update Posted: August 7, 2018
• Last Verified: July 2018

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:

Infection; Communicable Diseases