The aim of this study is investigation of effect of prone and supine and left lateral Positions on the arterial blood oxygenation and heart rate in very low birth weight neonates .Forty immature infant admitted in NICU of Babol hospitals participant in this study.they were selected randomly after vital sign stability and after 7 days of birth ,with less than 1500 gram weight ,and feeding via OG or breast feeding and without any respiratory problems .
Infants were excluded with Congenital anomaly, vascular disease, and pulmonary disease, gasterointestinal and neurological disorders .At first,the infants kept in supine Position for 2 hours, and then change their position to prone , at the end keep their position in left lateral . during this time we recorded all of parameters include arterial blood oxygen, heart rate and patient information on questionnaire every 15 minutes. We calculated mean of each parameters and compare these parameters together about their effect on oxygen saturation and heart rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030421340N1
Registration date:2015-06-08, 1394/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Samane Mirshahi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9593
Email address
s.mirshahi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of prone and supine and left lateral position on oxygen saturation and hart rate in very low birth weight
Public title
effects of position on oxygen saturation and hart reat in very low birth weight neonate
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age less than 37 weeks and weight less than 1500 gram , infant feeding via OG or breast feeding, and they should not have any respiratory problems.
Exclusion criteria: Congenital anomaly, vascular disease, and pulmonary disease, gastrointestinal and neurological disorders, they should not need respiratory support , or having umbilical catheter or chest tube
Age
From 7 days old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Babol University of Medical Sciences
Street address
Ganjafrooz Street
City
babol
Postal code
47754-47976
Approval date
2014-12-16, 1393/09/25
Ethics committee reference number
9339012
Health conditions studied
1
Description of health condition studied
preterm and low birth weight
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation
Primary outcomes
1
Description
oxygen saturation
Timepoint
every 15 minutes for 2 hours in each position during the study
Method of measurement
oximetric pulse
2
Description
hart reat
Timepoint
every 15 minutes for 2 hours in each position during the study
Method of measurement
monitor
Secondary outcomes
1
Description
decreased oxygen saturation
Timepoint
each position to 2 hours
Method of measurement
each position to 2 hours
2
Description
bradycardia
Timepoint
each position to 2 hours
Method of measurement
each position to 2 hours
Intervention groups
1
Description
positioning the newborns in prone position,positioning the newborns in supine position,positioning the newborns in left latral position
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Samane Mirshahi
Street address
University Square, Keshavarz Blvd. Ganjafrooz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Ganjafrooz Street
City
Babol
Grant name
Grant code / Reference number
9339012
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Samane Mirshahi
Position
Nurse
Other areas of specialty/work
Street address
Ganj afrooz street
City
Babol
Postal code
47976-47745
Phone
+98 11 3219 9596
Fax
+98 11 3219 0624
Email
s.mirshahi@mubabol.ac.ir ; s.mirshahi63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samane Mirshahi
Position
Nurse
Other areas of specialty/work
Street address
Ganj afrooz street
City
Babol
Postal code
47976-47745
Phone
+98 11 3219 9596
Fax
+98 11 3219 0624
Email
s.mirshahi@mubabol.ac.ir ; s.mirshahi63@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samane Mirshahi
Position
nurse
Other areas of specialty/work
Street address
Ganjafrooz Street
City
Babol
Postal code
47976-47745
Phone
+98 11 3219 9596
Fax
+98 11 3219 0624
Email
s.mirshahi@mubabol.ac.ir ; s.mirshahi63@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)