Skip to main content
OpenTrials
Completed

NCT Number: NCT01356147

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Infections

Age range

7 day–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Georgetown University Hospital, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dornase Alfa

Drug

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

Other names: Pulmozyme

Placebo

Drug

No therapy will be given to placebo arm

Other names: Sham therapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study 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

Acronym: PVAIN

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
May 19, 2011
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.