Position changes are believed to increase the efficacy of phototherapy and Turning of infants during phototherapy for hyperbilirubinemia is practiced in many nurseries, especially in our country. However, there is little research evidence in support of this practice. The aim of this study is to determine the effect of routine turning on the total serum bilirubin concentration and on the duration of phototherapy, versus only supine position.
Seventy full-term newborn infants with nonhemolytic hyperbilirubinemia [greater than or equal to 15 mg/dl] are studied. Neonates are enrolled in the study with the consent of appropriate ethic committee on research affair and the infant’s parents/ guardians. Convenience sampling is performed and infants are randomly divided into two groups. In “turning group”, changing from a supine to a prone position or vice versa is performed every 150 minutes. The “fix group” is kept in the supine position during the entire study period. Total serum bilirubin is obtained just prior to the initiation of phototherapy, 6, 12, 18, 24, 48 and 72 hours after phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111063250N4
Registration date:2011-12-04, 1390/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-04, 1390/09/13
Registrant information
Name
Bahareh Bahman Bijari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
bbbijari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Changing Position on Bilirubin Levels in Term Healthy Neonates with Jaundice During Phototherapy
Public title
The Effect of Changing Position on Bilirubin Levels in Term Healthy Neonates with Jaundice During Phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
All term infants weigh more than 2500 gr without congenital malformation with serum bilirubin level 15-23mg/dL are included. Exclusion criteria: age more than 10 days; ABO incompatibility hemolytic jaundice; any signs of infection including sepsis; Serum total Bilirubin concentration above than 23 mg which considered for high intensity phototherapy or blood transfusion.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical comittee for human research, Kerman university of medical sciences
Street address
Vice chancellor for research, Tahmasb Abad crossroad
City
Kerman
Postal code
Approval date
2011-11-06, 1390/08/15
Ethics committee reference number
k/90/227
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Total serum bilirubin concentration
Timepoint
hours 6, 12, 18, 24 and 72
Method of measurement
mg/dL using Autoanalyzer
2
Description
duration of phototherapy
Timepoint
hours 6, 12, 18, 24 and 72
Method of measurement
hour
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: changing baby position every 150 minutes
Category
Other
2
Description
Control group: fix supine position during the study
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpoor Afshar
Street address
vice chancellor for research, Tahmasb abad crossroad
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical sciences
Full name of responsible person
Dr Bahareh Bahman Bijari
Position
Neonatal fellowship/ professor
Other areas of specialty/work
Street address
Zafar 2 Avenue, 4th west alley
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
bbbijari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of medical sciences
Full name of responsible person
Dr Bahareh Bahman Bijari
Position
Neonatal fellowship
Other areas of specialty/work
Street address
Zafar 2 Av. 4th west alley
City
Kerman
Postal code
7618696815
Phone
+98 34 1322 2269
Fax
Email
bbbijari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of medical sciences
Full name of responsible person
Dr Pardis Sasani
Position
General practitioner
Other areas of specialty/work
Street address
No.2, phase 1, Kooye sarjangaldari, Jomhoori Blvd
City
Kerman
Postal code
7618747316
Phone
+98 34 1211 3882
Fax
Email
pardis_sasani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)