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van CCT (UK)

van CCT (UK)

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

- candidate number2156
- NTR NumberNTR725
- Date ISRCTN created28-sep-2006
- date ISRCTN requested27-sep-2006
- Date Registered NTR3-jul-2006
- Secondary IDsN/A 
- Public TitleEfficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis.
- Scientific TitleEfficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis.
- hypothesisRhDNase can liquefy mucus in children with an atelectasis during mechanical ventilation, resulting in improved mucociliary clearance, less mucus retention and less airways obstruction, thereby enhancing the rate of resolution of an atelectasis. Moreover we expect the ventilator settings, pulmonary ventilation and ventilation-perfusion mismatch to improve faster, possibly resulting in a shorter time spent on a ventilator and on the ICU.
- Healt Condition(s) or Problem(s) studiedAtelectasis, Mechanical ventilation
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-nov-2007
- Target number of participants80
- InterventionsIntervention 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 ml isotonic saline, for two days.
- Primary outcomeChange in a Chest radiograph-score (CXR-score) at 48 hours.
- Secondary outcomeChange 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsN/A
- Brief summaryAtelectasis in children during mechanical ventilation often results from and/or is associated with airway inflammation and airways infection, with an increased influx of inflammAatory cells in the airways. Inflammatory cells and damaged epithelial cells degrade, and release DNA in airway mucus resulting in an increased mucus viscosity. Viscous mucus impairs mucociliary clearance, resulting in airways obstruction and impaired resolution of atelectasis.

We therefore designed a study to evaluate the efficacy of the mucolytic medicine rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.
- Main changes (audit trail)
- RECORD3-jul-2006 - 13-jan-2010

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