Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis - RhDNase in ventilated pediatric patients

Conditions: Study population are: Children who develop an atelectasis during mechanical ventilation.An atelectasis is a collapsed part of the lung that is often caused by mucus plugs.

Registration Number: EUCTR2006-002098-30-NL

Lead Sponsor: Erasmus Medical Centre Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.<br>;Secondary Objective: Change from baseline in Chest radiograph-score at 24 hours, and change in: ventilatory settings; saturation; blood-gas values and DNA content in tracheal aspirates; duration of mechanical ventilation. ;Primary end point(s): Change from baseline in Chest radiograph-score at 48 hours.

Secondary Outcome Measures