In a clinical trial, we investigated effects of different positioning in 32 neonates who were under mechanical ventilation on their SPO2. At first, they were positioned in supine position for 120 minutes and then in prone position for another 120 minutes while their SPO2 were measuring by puls-oxymeter. During the intervention, they received no or minimum procedure and there were no change in setting of ventilator. They were excluded if they had thermal instability, receiving blood or blood products, or SPO2 les than 80% during the study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809292899N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Zahra Abdeyazdan
Name of organization / entity
Nursing and midwifery cares research center, Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 79229063110098
Email address
abdeyazdan@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller for Research of Isfahan University of Medical Sciences
Expected recruitment start date
2008-05-25, 1387/03/05
Expected recruitment end date
2008-08-21, 1387/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effects of prone and supine position in preterm neonates under mechanical ventilation in selected hospitals in Isfahan city
Public title
Investigation of effects of prone and supine position in preterm neonates under mechanical ventilation in selected hospitals in Isfahan city
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age less than 37 weeks, under mechanical ventilation from previous 4 hours, having no respiratory distress due to congenital heart disease, having no active bleeding, having no neuromuscular disease, having no pulmonary hypertension, no need to frequent changes in setting of ventilator
Exclusion criteria: thermal instability, receiving blood or blood products during the study, or SPO2 less than 80% during the study
Age
From 1 year old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
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
Ethics in Researches of Medical Sciences 0f Vice Chanceller for Research of Isfahan University of Me
Street address
Vice Chanceller for Research, Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Postal code
Approval date
2008-05-24, 1387/03/04
Ethics committee reference number
387041
Health conditions studied
1
Description of health condition studied
premature newborns under mechanical ventilation
ICD-10 code
P07.3
ICD-10 code description
Disorders related to length of gestation and fetal growth
Primary outcomes
1
Description
oxygenation
Timepoint
Every minute
Method of measurement
pulse oxymetery
Secondary outcomes
empty
Intervention groups
1
Description
positioning the newborns in supine position
Category
Treatment - Other
2
Description
positioning the newborns in prone position
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU, Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
NICU/ Al Zahra Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Isfahan University of Medical Sciences
Full name of responsible person
Dr Payman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Isfahan 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
Nursing and Midwifery Cares Research center, Nursing and Midwifery Faculty, Isfahn University of Med
Full name of responsible person
Zahra Abdeyazdan
Position
Associate professor, Pediatrician
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahn University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2906
Fax
Email
abdeyazdan@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Cares Research Center/ Nursing and Midwifery Faculty, Isfahn University of Med
Full name of responsible person
Zahra Abdeyazdan
Position
Medical Doctor, Pediatrician
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahn University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2906
Fax
Email
abdeyazdan@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and midwifery Cares Research Center, Nursing and midwifery faculty, Isfahn university of med
Full name of responsible person
Zahra Abdeyazdan
Position
MD/pediatrician
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)