Contact information
Type
Scientific
Primary contact
Dr Pavel Mazmanyan
ORCID ID
Contact details
Mashtots ave. 22
Yerevan
375002
Armenia
+374 (8)91 41 65 89
pavelart@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised-controlled trial comparing bubble and flow driver continuous positive airway pressure in preterm infants in a resource poor setting
Acronym
Study hypothesis
There are two principal devices currently available for the administration of Continuous Positive Airway Pressure (CPAP). These are the flow driver and bubble systems. The flow driver is now in established use in the developed world; there is currently renewed interest in the bubble CPAP system. The systems differ substantially in cost with bubble CPAP considerably cheaper. However their efficacy has not been formally compared. In order to be adopted as a standard of care it would be necessary to demonstrate that bubble CPAP is as or more efficacious than flow driver CPAP.
Ethics approval
Institutional Review Board (IRB) committee for clinical studies, American University of Armenia, 09/03/2007
Study design
Randomised and controlled, minimisation by sex and antenatal steroids
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
Neonatal Diseases: respiratory
Intervention
Trial procedures are exactly as would be performed in the course of standard care; the only difference is the selection of type of CPAP by randomisation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Total days receiving CPAP until the time of discharge from the unit.
Secondary outcome measures
1. Infants requiring ventilation
2. Deaths
3. Pneumothorax rate
4. Facial/nasal excoriation
Outcomes will be measured at the time of discharge from the unit.
Overall trial start date
24/03/2007
Overall trial end date
30/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Preterm infants
2. Parental consent
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
64 babies per group
Participant exclusion criteria
Major life-threatening congenital malformation.
Recruitment start date
24/03/2007
Recruitment end date
30/03/2009
Locations
Countries of recruitment
Armenia
Trial participating centre
Mashtots ave. 22
Yerevan
375002
Armenia
Sponsor information
Organisation
Scientific Research Centre of Maternal and Child Health (Armenia)
Sponsor details
Mashtots Av. 22
Yerevan
375002
Armenia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Birthlink (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
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26271753