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
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