Condition category
Respiratory
Date applied
09/04/2007
Date assigned
09/05/2007
Last edited
21/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.medlib.am/maternal/index.html

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26271753

Publication citations

Additional files

Editorial Notes

21/04/2016: Publication reference added.