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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30062

Enrollment

Registered

2006-06-06

Start date

2006-10-18

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atelectasis

Interventions

One group receives 2.5 mg of nebulized rhDNase twice daily, and the other group receives 2.5 ml of nebulized isotonic saline twice daily, until extubation, with a maximum of 4 doses. Study medicatio

Eligibility

Age

2 Years to 17 Years

Inclusion 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

Exclusion criteria: 1. Children with neuromuscular disorders and impaired ability to cough; cardiomyopathy; or cystic fibrosis. 2. Post-gestational age

Design outcomes

Primary

Measure	Time frame
Change from baseline in Chest radiograph-score at 48 hours.	—

Secondary

Measure	Time frame
Secondary endpoints: 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)