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Clinical Trials/NL-OMON30062
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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