The purpose of this randomized clinical trial is to investigate the effect of two level of pressure support ventilation on success of extubation in preterm neonates. We include 30 preterm neonates between 27-37 weeks of gestation who are under mechanical ventilation and ready for extubation in Pressure Support (PSV) mode. The intervention under study is extubation the neonates with two different level of pressure support 10 and 6 CmH2o respectively in two groups . Extubation Failure during 48 hours after extubation as the primary outcome of our study will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309302801N3
Registration date:2014-06-20, 1393/03/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-20, 1393/03/30
Registrant information
Name
Roya Farhadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3018
Email address
rfarhadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran university of Medical Science
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two level of pressure support ventilation on success of extubation in preterm neonates
Public title
level of pressure support ventilation on success of extubation in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all neonates 27-37 weeks gestation; under mechanical ventilation at least 48 hours due to RDS; is in Weaning Phase.
Exclusion Criteria: Pneumothorax; congenital anomalies; meconium aspiration pneumonia; congenital heart disease;asphyxia
Age
From 1 day old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University Of Medical Sciences
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street
City
Sari
Postal code
4817844718
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
399-14-12-92
Health conditions studied
1
Description of health condition studied
Extubation failure
ICD-10 code
P28.5
ICD-10 code description
Respiratory failure of newborn
Primary outcomes
1
Description
Extubation failure
Timepoint
48 hours after intervention
Method of measurement
observation
Secondary outcomes
1
Description
Death
Timepoint
72 hours after extubation
Method of measurement
observation
2
Description
pneomotorax
Timepoint
72 hours after extubation
Method of measurement
observation
3
Description
weaning time
Timepoint
from biginning of PSV mode till extubation point
Method of measurement
observation & documentation
4
Description
tidal volume
Timepoint
3 times during PSV mode till extubation
Method of measurement
internal measurement by ventilator device
5
Description
work of breathing
Timepoint
3 times during PSV mode till extubation
Method of measurement
internal measurement by ventilator device
6
Description
dynamic compliance
Timepoint
3 times during PSV mode till extubation
Method of measurement
internal measurement by ventilator device
Intervention groups
1
Description
Intervention 1:Extubation from mechanichal ventilator while neonates receive 10 CmH2O of Pressure in Pressure Support mode/
Category
Treatment - Devices
2
Description
Intervention2: Extubation from mechanichal ventilator while neonates receive 6 CmH2O of Pressure in Pressure Support mode
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali-Sina Hospital
Full name of responsible person
Roya Farhadi
Street address
Pasdaran bulevard-Boo Ali-Sina Hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant professor/ Neonatologist
Other areas of specialty/work
Street address
Faculty of Medicine- Boo Ali Sina hospital
City
Sari
Postal code
48166-33131
Phone
+98 15122330114
Fax
Email
dr.royafarhadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant Professor, Neonatologist
Other areas of specialty/work
Street address
Boo ali Sina hospital
City
Sari
Postal code
Phone
+98 151223301114
Fax
+98 15 1223 2506
Email
dr.royafarhadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Neonatologist/Assistant Professor
Other areas of specialty/work
Street address
Boo ali sina Hospital
City
Sari
Postal code
Phone
+98 151223301114
Fax
Email
dr.royafarhadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)