A randomised-controlled trial comparing bubble and flow driver continuous positive airway pressure in preterm infants in a resource poor setting
| ISRCTN | ISRCTN22578364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22578364 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/04/2007
- Registration date
- 09/05/2007
- Last edited
- 21/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pavel Mazmanyan
Scientific
Scientific
Mashtots ave. 22
Yerevan
375002
Armenia
| Phone | +374 (8)91 41 65 89 |
|---|---|
| pavelart@gmail.com |
Study information
| Study design | Randomised and controlled, minimisation by sex and antenatal steroids |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised-controlled trial comparing bubble and flow driver continuous positive airway pressure in preterm infants in a resource poor setting |
| Study objectives | 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(s) | Institutional Review Board (IRB) committee for clinical studies, American University of Armenia, 09/03/2007 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 24/03/2007 |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 64 babies per group |
| Key inclusion criteria | 1. Preterm infants 2. Parental consent |
| Key exclusion criteria | Major life-threatening congenital malformation. |
| Date of first enrolment | 24/03/2007 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- Armenia
Study participating centre
Mashtots ave. 22
Yerevan
375002
Armenia
375002
Armenia
Sponsor information
Scientific Research Centre of Maternal and Child Health (Armenia)
Hospital/treatment centre
Hospital/treatment centre
Mashtots Av. 22
Yerevan
375002
Armenia
| Website | http://www.medlib.am/maternal/index.html |
|---|---|
"ROR" |
https://ror.org/00zw38x02 |
Funders
Funder type
Charity
Birthlink (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No |
Editorial Notes
21/04/2016: Publication reference added.
