Efficacy of inhaled recombinant human deoxyribonuclease in mechanically ventilated pediatric patients with an atelectasis
| ISRCTN | ISRCTN07263575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07263575 |
| Secondary identifying numbers | NTR725 |
- Submission date
- 28/09/2006
- Registration date
- 28/09/2006
- Last edited
- 06/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Boogaard
Scientific
Scientific
Erasmus Medical Center
Sophia Childrens Hospital
Department of Pediatric Pulmonology
SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 4636683 |
|---|---|
| r.boogaard@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Recombinant human deoxyribonuclease (rhDNase) can liquefy mucous in children with an atelectasis during mechanical ventilation, resulting in improved mucociliary clearance, less mucous retention and less airway 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 Intensive Care Unit (ICU). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Atelectasis during mechanical ventilation |
| Intervention | 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 ml isotonic saline, for two days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Recombinant human deoxyribonuclease (rhDNase) |
| Primary outcome measure | Change in a Chest radiograph-score (CXR-score) at 48 hours. |
| Secondary outcome measures | 1. Change in a Chest radiograph-score at 24 hours 2. Change in: a. ventilatory settings b. saturation c. blood-gas values d. DeoxyriboNucleic Acid (DNA) content and cytokines in tracheal aspirates e. duration of mechanical ventilation f. length of stay |
| Overall study start date | 01/09/2006 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Aged zero to 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 six hours (maximum 12 hours) after an atelectasis has been diagnosed |
| Key exclusion criteria | 1. Children with neuromuscular disorders and impaired ability to cough, cardiomyopathy, or cystic fibrosis 2. Post-gestational age less than 32 weeks 3. Mechanical ventilation during muscle paralysis 4. Atelectasis due to a bronchoscopically diagnosed: a. foreign body aspiration b. 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 nebulising medication (according to the responsible physician) 8. Presence of a pneumothorax 9. Previous participation in the study |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Erasmus Medical Center, Sophia Children's Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
"ROR" |
https://ror.org/047afsm11 |
|---|
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
