Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis

Phase 3

Recruiting

• Conditions: atelectasis; partly collapsed lung; 10024967

• Registration Number: NL-OMON30062
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Age 0-18 years
2. Mechanical ventilation
3. Presence of an atelectasis on a chest radiograph (CXR)
4. First dose of study medication can be administered within 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 < 32 weeks
3. Mechanical ventilation during muscle paralysis
4. Atelectasis due to a bronchoscopically diagnosed:
- foreign body aspiration
- tracheal or bronchial compression by lymph nodes or vessels
5. RhDNase treatment in the previous 48 hours.
6. Clinical condition or ventilator settings that are not compatible with nebulizing medication (according to the responsible physician)
7. Presence of a pneumothorax

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in Chest radiograph-score at 48 hours. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: Change from baseline in Chest radiograph-score at 24<br /><br>hours, and change in: ventilatory settings; saturation; blood-gas values and<br /><br>DNA content in tracheal aspirates; duration of mechanical ventilation. </p><br>