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

Georgetown University

Status and phase: Completed; Phase 4

Conditions: Pulmonary Infections

Treatments: Drug: Dornase alfa; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01356147

Z4962s

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 7 days to 4 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Sham placebo

Sham Comparator group

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.

Treatment:

Drug: Placebo

Dornase alfa

Active Comparator group

Description:

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

Treatment:

Drug: Dornase alfa