Aim: This cross over study was conducted to determine the effect of body position on the arterial oxygen saturation of healthy premature neonates. Totally 88 healthy premature neonates which were just feeding and being prepared to discharge, randomly selected. The neonates first randomly placed in prone or supine position, and 30 min later SpO2 was measured over a 30 min interval. Then, the infants turned from prone to supine or from supine to prone, and a repeat set of measurement was made.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905063900N2
Registration date:2011-11-17, 1390/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-17, 1390/08/26
Registrant information
Name
Zohre Torabi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 4857
Email address
mohamad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2010-01-06, 1388/10/16
Expected recruitment end date
2010-11-01, 1389/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of body position on the arterial oxygen saturation of healthy premature neonates
Public title
The effect of body position on the arterial oxygen saturation of healthy premature neonates
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy premature neonates who were feeding and being prepared to discharge. Exclusion criteria: Not healthy premature neonates.
Age
From 1 year old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences
City
Zanjan
Postal code
Approval date
2009-06-27, 1388/04/06
Ethics committee reference number
8846
Health conditions studied
1
Description of health condition studied
arterial oxygen saturation of healthy premature neonates
ICD-10 code
J70
ICD-10 code description
Respiratory conditions due to other external agents
Primary outcomes
1
Description
SpO2
Timepoint
30 minutes
Method of measurement
puls oximetry
Secondary outcomes
empty
Intervention groups
1
Description
prone position
Category
Other
2
Description
supine position
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciencs
Full name of responsible person
Alireza Biglari
Street address
Zanjan University of Medical Sciences
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciencs
Full name of responsible person
Alireza Biglari
Street address
Zanjan University Of Medical Sciencs
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciencs
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
Zanjan University of Medical Sciences
Full name of responsible person
Zohre Torabi
Position
Assistant prof, specialist of pediatic
Other areas of specialty/work
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Postal code
Phone
+98 24 1727 4857
Fax
+98 24 1413 1140
Email
drztorabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zohre Torabi
Position
Assistant prof., specialist of pediatic
Other areas of specialty/work
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Postal code
4515613191
Phone
+98 24 1727 4857
Fax
+98 24 1413 1140
Email
drztorabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)