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

NCT01356147 | Completed Phase 4 Results

• 1 other identifier: Z4962s
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Infections

Keywords

ventilator associated pulmonary infections

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in Oxygen Requirement From Baseline

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

  First week of treatment or extubation

Secondary Outcomes (2)

• Elimination of White Blood Cells and Bacteria From Tracheal Aspirate

  During first week of treatment or until extubation whichever is earlier

• Number of Infants Requiring Ventilator Support

  7 days

Study Arms (2)

Sham placebo

SHAM COMPARATOR

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

Dornase alfa

ACTIVE COMPARATOR

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

Drug: Dornase alfa

Interventions

Dornase alfa DRUG

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

Also known as: Pulmozyme

Dornase alfa

Placebo DRUG

No therapy will be given to placebo arm

Also known as: Sham therapy

Sham placebo

Eligibility Criteria

• Age: 7 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Georgetown University Hospital NICU

Washington D.C., District of Columbia, 20007, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

dornase alfa

Results Point of Contact

• Title: Dr. Melissa Scala
• Organization: Stanford University School of Medicine/Division of Neonatology

mscala@stanford.edu

650-724-9653

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Department of Neonatology

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: April 30, 2017
• Last Updated: August 7, 2018
• Results First Posted: February 8, 2017

Record last verified: 2018-07

Locations

US (2)