This study will conduct for effects of Kangoroo care mothers on vital signs and O2 saturation in neonates of NICU in Shahid Sadoughi Hospital of Yazd. This randomized clinical trial will be done on 50 hospitalized newborns which have inclusion criteria for study and then divide in two groups (n=25). inclusion criteria are :gestational age>32 weeks;weight >1800gram and without problem in respiratory, cardiovascular and CNS .Intervention group will be given kangaroo mother care in three consequence days one hour in a day .Newborns will be placed vertically between the mothers breasts and supported in bottom with a sling /blinder. Neonates in the control group will be given conventional care in incubator.Both groups will be monitored for temperature,heart rate,respiratory rate, and o2 saturation at 1 hour after care .Two groups will be compared in vital signs and O2 saturation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901223679N1
Registration date:2011-10-21, 1390/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-21, 1390/07/29
Registrant information
Name
Khadijeh Dehghani
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences, Yazd,Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
dehghanish@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kangoroo care mothers on vital signs and O2 saturation of neonates in NICU of Shaheed Sadooghi Hospital
Public title
Effect of Kangoroo care in newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonatal age 32 weeks or more;Weight 1800 gr or more;Neonates without problem in respiratory, cardiovascular and CNS
Exclusion criteria: Neonates without inclusion criteria; and their parents dont want to participate
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
shahid sadoughi University of Medical sciences
Street address
bahonar square in yazd
City
yazd
Postal code
Approval date
2009-05-16, 1388/02/26
Ethics committee reference number
14810/1/17/p
Health conditions studied
1
Description of health condition studied
new born preterm
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
Temprature
Timepoint
before-half an hour after-in finishing one hour
Method of measurement
NICU termometer
2
Description
respiration
Timepoint
before-half an hour after-in finishing one hour
Method of measurement
monitor in Nicu
3
Description
heart rate
Timepoint
before-half an hour after-in finishing one hour
Method of measurement
monitor in Nicu
4
Description
o2 saturation
Timepoint
before-half an hour after-in finishing one hour
Method of measurement
pulse oximeter in Nicu
Secondary outcomes
empty
Intervention groups
1
Description
Kangoro care is done by mothers for their newborns with researcher,s supervision and support for one hour in a day in three sequence day
Category
N/A
2
Description
control group:neonates in the control group will be given conventional care in incubator.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadoughi Hospital,Yazd
Full name of responsible person
ِKhadijeh Dehghani
Street address
Nursing and Midwifery ,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Street address
Shahid Sadoughi University of Medical Sciences, Nursing and Midwifery College
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Ms
Other areas of specialty/work
Street address
Nursing and Midwifery College
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
dehghanish@ssu.ac.irkhadi20y@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences ,yazd,iran
Full name of responsible person
Khadije Dehghani
Position
master science,faculty member
Other areas of specialty/work
Street address
nursing and midwifery college
City
Yazd
Postal code
Phone
+98 913 153 5531
Fax
Email
dehghanish@ssu.ac.irkhadi20y@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dehghani
Full name of responsible person
Khadijeh
Position
master science,faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery college,Yazd
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
+98 35 1824 9705
Email
khadi20y@yahoo.comdehghanish@ssu.ac.ir
Web page address
www.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)