The aim of this study was to determine the effect of turning (supine and prone position intermittently) versus supine position on the total serum bilirubine concentration during phototherapy. In a randomized controlled trial, term jaundice neonates who were admitted to the neonatal ward of Emamreza hospital were selected. Group1 changed from supine to prone position every 150 minutes. Supine group (group2) was kept in supine position during the entire study period. Total and direct bilirubine level measured at the beginning and 12, 24, 48 hours after phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711061162N12
Registration date:2009-06-07, 1388/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-07, 1388/03/17
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2003-05-21, 1382/02/31
Expected recruitment end date
2004-05-21, 1383/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Supine versus turning position effect on bilirubine level during phototherapy in healthy term jaundice neonates
Public title
Supine versus turning position effect on bilirubine level during phototherapy in healthy term jaundice neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy baby, breastfeeding, 49 hours postnatal age, birth weight more than 2500gr, 38-41 weeks gestational age and delivered during an uncomplicated pregnancy.
Exclusion criteria: Infants with hemolytic disease, infection, congenital anomaly, closed hemorrhage (cephalo-hematoma) and metabolic disease.
Age
No age limit
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
Vice chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2003-09-04, 1382/06/13
Ethics committee reference number
825-2297
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P61.9
ICD-10 code description
Perinatal haematological disorder, unspecified
Primary outcomes
1
Description
serum bilirubine
Timepoint
befor intervention-12,24 and 48 after phototherapy
Method of measurement
Venous sampling and blood serum bilirubine (diazo method)
Secondary outcomes
1
Description
jaundice in neonate
Timepoint
daily
Method of measurement
Clinically judgment of Icter
Intervention groups
1
Description
Change position from supine position to prone position during phototherapy every 150 minutes
Category
empty
2
Description
Supine position during phototherapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
the neonatal ward of Emamreza hospital
Full name of responsible person
Dr.Ashraf mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Dr jalil tavakol afshari
Street address
Ghoreshi bulding-Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)