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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21415
Enrollment
80
Registered
2006-07-03
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Atelectasis during mechanical ventilation.

Interventions

Intervention group: Twice daily: inhaled rhDNase, 2.5 ml and twice daily 4 ml isotonic saline (NaCl 0.9%), for two days. Control group: Twice daily: inhaled isotinic saline 2.5 ml and twice daily 4 m

Sponsors

Erasmus Medical Center, Sophia Children's Hospital. Dr. Molewaterplein 60, 3015 GJ Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 0-18 years; 2. Mechanical ventilation; 3. Presence of an atelectasis on a chest radiograph; 4. First dose of study medication can be administered preferably within 6 hours (max 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 < 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. Recurrent atelectasis due to an anatomical airway-abnormality; 6. RhDNase treatment in the previous 48 hours; 7. Clinical condition or ventilator settings that are not compatible with nebulizing medication (according to the responsible physician); 8. Presence of a pneumothorax; 9. Previous participation in the study.

Design outcomes

Primary

MeasureTime frame
Change in a Chest radiograph-score (CXR-score) at 48 hours.

Secondary

MeasureTime frame
Change in a Chest radiograph-score at 24 hours, and change in: ventilatory settings; saturation; blood-gas values; DNA content and cytokines in tracheal aspirates; duration of mechanical ventilation; length of stay.

Contacts

Public ContactR. Boogaard

Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology, SB-2666, P.O. Box 2060

r.boogaard@erasmusmc.nl+31 (0)10 4636683

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)