To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in Chest radiograph-score at 48 hours.
Secondary outcome
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.
Background summary
Atelectasis in children during mechanical ventilation often results from and/or
is associated with airway inflammation and airways infection, with an increased
influx of inflammatory 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.
Study objective
To evaluate the efficacy of inhaled rhDNase in addition to conventional
treatment in children with an atelectasis during mechanical ventilation.
Study design
A double blind, randomized, placebo-controlled clinical trial
Intervention
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 medication is given as add-on therapy. The
routine care consists of inhaled isotonic saline, airway clearance therapy,
recruitment strategies with the ventilator and bronchoscopy when indicated.
Study burden and risks
Burden: Standard treatment of mechanically ventilated children with an
atelectasis consists of (among others) nebulized isotonic saline 4 times daily.
During the study period, two nebulizations with isotonic saline will be
replaced with study medication. Consequently, the total number of nebulizations
will be the same.
After inclusion, two chest radiographs will be made. The only difference with
routine patient care is, that during the study period the chest radiographs
will be made after a prespecified time-period. In most children with an
atelectasis during mechanical ventilation, chest radiographs would have been
made anyway to assess resolution or progression of the atelectasis.
A tracheal aspirate is collected by means of tracheal suctioning, a
routine-procedure that has to be performed regularly in ventilated children.
Material collected during routine tracheal suctioning will be used for
analysis.
Blood gas values will be obtained in children with an arterial line only.
Therefore no physiological discomfort is to be expected.
Risks: Based on the current literature, it can be concluded that
administration of rhDNase in infants and young children on mechanical
ventilation for acute respiratory symptoms is safe. Reported side effects of
rhDNase, are mild and transient and include pharyngitis, rhinitis and
hoarseness. Children who might experience difficulty in coughing up thin mucus
theoretically, are excluded from the study (premature infants, paralyzed
patients, children with neuromuscular disease).
dr molewaterplein 60
3015 GJ Rotterdam
NL
dr molewaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002098-30-NL |
| CCMO | NL12247.078.06 |