Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/03/2007
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 M C J Kneyber

ORCID ID

Contact details

VU Medical Centre
Office 8 D 11
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2413
m.kneyber@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

1. First, mechanical ventilation with a gas mixture composed of helium and oxygen is only beneficial in patients with obstructive Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD). Hence correct identification of the clinical phenotype is necessitated. This can be done with lung function testing, including compliance and resistance.
2. Second, the beneficial effect of heliox can be detected with repeated Electrical Impedance Tomography (EIT) measurements.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD)

Intervention

Mechanical ventilation with heliox.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Respiratory system mechanics (compliance and resistance).

Secondary outcome measures

Arterial partial pressure of Carbon Dioxide (pCO2).

Overall trial start date

01/10/2005

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Mechanically ventilated infants younger than 12 months of age with a virologically proven RSV infection.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

15

Participant exclusion criteria

Older than 12 months of age, no informed consent, prior use of corticosteroids, infants on high-frequency oscillatory ventilation and infant wit a haemodynamically significant congenital heart defect.

Recruitment start date

01/10/2005

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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