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

NCT ID: NCT01356147

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

No therapy will be given to placebo arm

Dornase alfa

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

Group Type: ACTIVE_COMPARATOR

Dornase alfa

Intervention Type: DRUG

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

Interventions

Dornase alfa

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

Intervention Type: DRUG

Placebo

No therapy will be given to placebo arm

Intervention Type: DRUG

Other Intervention Names

Pulmozyme; Sham therapy

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Scala

Assistant Professor of Pediatrics, Department of Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Georgetown University Hospital NICU

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

Georgetown University Hospital

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

Countries

United States

Other Identifiers

Z4962s

Identifier Type: -

Identifier Source: org_study_id