Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0217106473
Study information
Scientific title
Volume controlled ventilation for treatment of respiratory failure in preterm infants
Acronym
Study hypothesis
Is there any significant difference in length of ventilation in babies randomised to receive volume controlled or time-cycled pressure limited ventilation?
Ethics approval
Not provided at time of registration
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 to request a patient information sheet
Condition
Neonatal Diseases: Respiratory
Intervention
Randomised controlled trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Length of ventilation required
Secondary outcome measures
1. Incidence of air leak
2. Intraventricular hemorrhage (IVH)
3. Necrotising enterocolitis (NEC)
Overall trial start date
01/03/2002
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Babies of <500-1500 g requiring ventilation
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/03/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hope Hospital
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Salford Royal Hospitals NHS Foundation Trust (UK)
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