The purpose of this study was to evaluate the effect of Massage therapy on transcutaneus bilirubin in healthy term neonates . The main inclusion criteria included gestational age more than 37,birth weight=or>2500, breast feeding and postnatal age less than 12 h of life .The exclusion criteria were congenital anomaly, cephalhematoma .blood group incompatibility ,sepsis, formula feeding, exchange transfusion in previous sibling. Term newborns with postnatal age less than 12 h were included.The sample size included 100 uncomplicated neonates whom were randomly assigned into two different groups. massage group and control group. In both group transcutaneous bilirubin level measured from the first day to the fifth day postnatally . Normal care was given to the control group without massage. For massage group, specialized clinical staff gave 15-20 minutes of baby massage once daily from the first day to the fifth day postnatally ,according Miami protocol. The main outcome of this study was to see the effect of massage , on the level of transcutaneous bilirubin.The neonates were checked for the frequency of stool.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010274961N3
Registration date:2012-10-23, 1391/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-23, 1391/08/02
Registrant information
Name
Homa Babaei
Name of organization / entity
Kermanshah University of Medical Secinces
Country
Iran (Islamic Republic of)
Phone
00988314276303 داخلی 2292
Email address
homa_babaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of Massage therapy effect on transcutaneus bilirubin in healthy term neonates
Public title
A survey of Massage therapy effect on transcutaneus bilirubin in healthy term neonates
Purpose
Prevention
Inclusion/Exclusion criteria
The main inclusion criteria included gestational age more than 37,birth weight=or>2500, breast feeding and postnatal age less than 12 h and those of the exclusion were congenital anomaly, cephalhematoma،blood group incompatibility ,sepsis, formula feeding, exchange transfusion in previous sibling
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Bulding no=2, Sepah Avenue, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714415333
Approval date
2012-03-18, 1390/12/28
Ethics committee reference number
7/420/62999پ
2
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Bulding no=2,shahid beheshti Avenue, Kermanshah University of Medical Sciences
City
kermanshah
Postal code
6714415333
Approval date
2012-03-18, 1390/12/28
Ethics committee reference number
7/420/62999پ
Health conditions studied
1
Description of health condition studied
neonatal hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
transcutaneus bilirubin
Timepoint
each 24 h
Method of measurement
by bilimeter
Secondary outcomes
1
Description
stool frequency
Timepoint
each 24
Method of measurement
inspection by mother
Intervention groups
1
Description
For massage group,(from the first day to the fifth day postnatal) clinical staff gave 15-20 minutes of baby massage once daily according university of Miami protocol
Category
Prevention
2
Description
newborns in the control group underwent routine daily care (without massage) and transcutaneous bilirubin level measured (from the first day to the fifth day postnatal) daily.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences,
Full name of responsible person
Homa Babaei
Street address
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr farid Najafi
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
kermanshah
Postal code
671441533
Phone
+98 83 1427 6303
Fax
Email
homa_babaei @kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
kermanshsh
Postal code
Phone
+98 83 1427 6303
Fax
Email
homa_babaei@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei
Position
Neonatologist
Other areas of specialty/work
Street address
Department of pediatrics, Imam Reza Hospital, Kermanshah
City
kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
homa_babaei@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)