NL-OMON30062
Recruiting
Phase 3
Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis - RhDNase in ventilated pediatric patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- atelectasis
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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