Objectives: Survey of effect of touch as a complement for phototherapy on the reduction level of bilirubin in icteric newborns Design: Not blinded randomized clinical trial Setting and conduct: 60 icteric newborns will be divided into two groups, intervention(n=30) and control(n=30).The intervention group moreover phototherapy will be touched, but the control group were only treated with phototherapy. Major Inclusion and Exclusion criteria: Inclusion criteria: Full-term newborns weighing over 2000 grams; with Apgar score between 8-10; exclusive breastfeeding with mothers milk and having bilirubin greater than 12 milligrams per deciliter Exclusion criteria: Preterm infants with birth weight less than 2000 grams; having skin diseases; blood disorders; heart problems; hypothyroidism Intervention: The process of touching will be done by a trained person, 4 times a day, for 15 minutes, for two days Main outcome measures (variables): Bilirubin levels of blood
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015070122583N2
Registration date:2016-02-06, 1394/11/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Mohsen Shoja
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 85 3722 2469
Email address
mohsenshoja61@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Esfarayen Faculty of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of touch as a complement for phototherapy on the reduction level of bilirubin in icteric newborns
Public title
Effect of touch as a complement for phototherapy on the reduction level of bilirubin in icteric newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: full-term newborns weighing over 2000 grams; with Apgar score between 8-10; exclusive breastfeeding with mothers milk and having bilirubin greater than 12 milligrams per deciliter
Exclusion criteria: preterm infants with birth weight less than 2000 grams; having skin diseases; blood disorders; heart problems; hypothyroidism.
Age
To 6 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocking randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfarayenّ Faculty of Medical Sciences
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.ESFARAYENUMS.REC.1394.10
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P 59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Bilirubin in blood of newborns
Timepoint
Every 24 hours
Method of measurement
milligrams per deciliter
Secondary outcomes
1
Description
Discharge of newborns
Timepoint
day
Method of measurement
a day
Intervention groups
1
Description
Intervention group: In addition to doing phototherapy that will be done for 90 minutes and will be stopped for 30 minutes alternately, newborn's body touched by a trained person, 4 times a day , each time for 15 minutes for two days
Category
Other
2
Description
control group: Phototherapy will be done for 90 minutes and will be stopped for 30 minutes alternately.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital of Esfarayen
Full name of responsible person
Mohammad Shoja
Street address
Emam Khomeini Hospital, Esfarayen, North Khorasan
City
Esfarayen
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Esfarayen faculty of Medical Sciences, Esfarayen
Full name of responsible person
Mohsen Shoja
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Esfarayen faculty of Medical Sciences, Esfarayen
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
Esfarayen Faculty of Medical Sciences, Esfarayen
Full name of responsible person
Mohsen Shoja
Position
MSc of Epidemiology
Other areas of specialty/work
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Postal code
Phone
+98 58 3724 1601
Fax
Email
mohsenshoja61@yahoo.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences, Bojnurd
Full name of responsible person
Mohammad Shoja
Position
Assistant professor
Other areas of specialty/work
Street address
University of Medical Sciences, Shahriar Street, Bojnurd, North Khorasan
City
Bojnurd
Postal code
Phone
+98 58 3722 3569
Fax
Email
mshoja84@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Full name of responsible person
Mohsen Shoja
Position
Msc of Epidemiology
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Postal code
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)