Efficacy of inhaled recombinant human deoxyribonuclease in mechanically ventilated pediatric patients with an atelectasis

Completed

• Conditions: Atelectasis during mechanical ventilation; Respiratory

• Registration Number: ISRCTN07263575
• Lead Sponsor: Erasmus Medical Center, Sophia Children's Hospital (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged zero to 18 years
2. Mechanical ventilation
3. Presence of an atelectasis on a chest radiograph
4. First dose of study medication can be administered preferably within six hours (maximum 12 hours) after an atelectasis has been diagnosed

Exclusion Criteria

1. Children with neuromuscular disorders and impaired ability to cough, cardiomyopathy, or cystic fibrosis
2. Post-gestational age less than 32 weeks
3. Mechanical ventilation during muscle paralysis
4. Atelectasis due to a bronchoscopically diagnosed:
a. foreign body aspiration
b. tracheal or bronchial compression by lymph nodes or vessels
5. Recurrent atelectasis due to an anatomical airway-abnormality
6. RhDNase treatment in the previous 48 hours
7. Clinical condition or ventilator settings that are not compatible with nebulising medication (according to the responsible physician)
8. Presence of a pneumothorax
9. Previous participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in a Chest radiograph-score (CXR-score) at 48 hours.

Secondary Outcome Measures

Name	Time	Method
1. Change in a Chest radiograph-score at 24 hours<br>2. Change in:<br>a. ventilatory settings<br>b. saturation<br>c. blood-gas values<br>d. DeoxyriboNucleic Acid (DNA) content and cytokines in tracheal aspirates<br>e. duration of mechanical ventilation<br>f. length of stay