Condition category
Respiratory
Date applied
28/09/2006
Date assigned
28/09/2006
Last edited
06/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Boogaard

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s Hospital
Department of Pediatric Pulmonology
SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR725

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Recombinant human deoxyribonuclease (rhDNase)

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Sophia Children's Hospital (Netherlands)

Sponsor details

Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes