The goal of this study was to compare the effect of intermittent versus continuous phototherapy to reduce neonatal hyperbilirubinemia. In this prospective randomized trial, 96 neonates with hyperbilirubinemia who were admitted to Neonatal ward of Besat Hospital in Hamedan, Iran, were assigned into the two following groups. The neonates in the first group received continuous phototherapy (2 hours on, 0.5 hours off) while in the second group received intermittent phhototherapy (1 hours on, 1 hour off). Phototherapy units were equipped with 4 special blue tubes (Tosan Co) Placed 15-20 cm above the neonate’s body to produce an average irradiance of 20 mw /cm2 /nm at 420-470 nm, The neonate’s total serum billirubin level was measured every 12 hours after starting phototherapy and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012255459N1
Registration date:2011-02-10, 1389/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-10, 1389/11/21
Registrant information
Name
Kamran Sabzian
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0050
Email address
k.sabzian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences and Health Services
Expected recruitment start date
2009-08-22, 1388/05/31
Expected recruitment end date
2010-08-22, 1389/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of intermittent versus continuous phototherapy for reducing neonatal hyperbilirubinemia in Besat hospital of Hamedan.
Public title
Compariing the effect of intermittent versus continuous phototherapy for reducing neonatal icter.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: neonate between 2-14 day old, body weight more than 2500 grams, absence of other concomitant diseases, bilirubin between 16mg/dl and 22 mg/dl, obtaining approval letter from the ethics committee
Exclusion criteria: body weight under 2500 grams, presence of any concomitant diseases, need to blood exchange, need to intensive phototherapy, gestational age lower than 37 weeks, prolonged icterus (more than 14 day), direct bilirubin more than2 mg/dl
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Hamedan University of Medical Sciences and Health Services
Street address
Opposite Mardom park, Abbas abad St., Hamedan
City
Hamedan
Postal code
Approval date
2009-08-08, 1388/05/17
Ethics committee reference number
67853/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Indirect bilirubin
Timepoint
12, 24, 36, 48 hours after beginning of phototherapy
Method of measurement
mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
Intermittent phototherapy group received phototherapy for one hour and then one hour off intermittently. Phototherapy units were equipped with 4 special blue tubes (Tosan Co), placed 15-20 cm above the infant’s body to produce an average irradiance of 20 mw /cm2 /nm at 420-470 nm. This cycle was done for 48 hour.
Category
Treatment - Other
2
Description
Continuous phototherapy group (control group) received phototherapy for two hours and then half an hour off. Phototherapy units were equipped with 4 special blue tubes (Tosan Co) placed 15-20 cm above the infant’s body to produce an average irradiance of 20 mw /cm2 /nm at 420-470 nm. This cycle was done for 48 hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital of Hamedan University of Medical Sciences
Full name of responsible person
Kamran Sabzian
Street address
Besat Hospital, Besat street, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Kamran Sabzian
Street address
Besat Hospital, Besat St, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences and Health Services
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
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Kamran Sabzian
Position
Resident
Other areas of specialty/work
Street address
Besat Hospital, Besat St, Hamedan, Iran
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
k.sabzian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Kamran Sabzian
Position
Resident
Other areas of specialty/work
Street address
Besat Hospital, Besat St, Hamedan, Iran
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
k.sabzian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences and Health Services
Full name of responsible person
Kamran Sabzian
Position
Resident
Other areas of specialty/work
Street address
Besat Hospital, Besat St, Hamedan, Iran
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
k.sabzian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)