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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002098-30-NL

Enrollment

Registered

2006-06-01

Start date

2006-09-04

Completion date

Unknown

Last updated

2012-03-19

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

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.

Interventions

Trade Name: Pulmozyme Product Name: Pulmozyme Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, liquid Route of administration of the placebo: Inh

Eligibility

Sex/Gender

All

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. 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation. ;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.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation. ;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.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026