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

Phase 4

Completed

• Conditions: Pulmonary Infections
• Interventions: Drug: Placebo; Drug: Dornase alfa

• Registration Number: NCT01356147
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-29
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Primary Completion: 2015-01
• Results First Submitted: 2016-12-15
• Results First Submitted QC: 2016-12-15
• Results First Posted: 2017-02-08
• Study Completion: 2017-04-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham placebo	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.
Dornase alfa	Dornase alfa	Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Primary Outcome Measures

Name	Time	Method
Percent Reduction in Oxygen Requirement From Baseline	First week of treatment or extubation	Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Elimination of White Blood Cells and Bacteria From Tracheal Aspirate	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
Number of Infants Requiring Ventilator Support	7 days	number of infants extubated during treatment/sham

Trial Locations

Locations (2)

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Georgetown University Hospital NICU; 🇺🇸 Washington, District of Columbia, United States