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 |
| Protocol serial number | N/A |
| Sponsor | Scientific Research Centre of Maternal and Child Health (Armenia) |
| Funder | Birthlink (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised and controlled, minimisation by sex and antenatal steroids |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Total days receiving CPAP until the time of discharge from the unit. |
| Key secondary outcome measure(s) |
1. Infants requiring ventilation |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 128 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/04/2016: Publication reference added.
