Intermittent versus continuous phototherapy for the treatment of neonatal non-hemolytic moderate hyperbilirubinemia in infants more than 37 weeks of gestational age: a randomized controlled trial
This prospective randomized case control study is performed on 60 neonates with indirect hyperbilirubinemia who are admitted to neonatal ward in Loghman hospital in Tehran, Iran. The neonates are randomly divided into two groups, 30 neonates in continuous (Group I) and 30 in intermittent (Group II) phototherapy group.Then we compare the primary and secondary outcomes in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112225184N1
Registration date:2017-03-17, 1395/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-17, 1395/12/27
Registrant information
Name
Roya Taheri Tafti
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 8037
Email address
royataheritafti@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intermittent versus continuous phototherapy for the treatment of neonatal non-hemolytic moderate hyperbilirubinemia in infants more than 37 weeks of gestational age: a randomized controlled trial
Public title
Intermittent versus continuous phototherapy for the treatment of neonatal non-hemolytic moderate hyperbilirubinemia in infants more than 37 weeks of gestational age: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
This study has been performed on 60 neonates with indirect hyperbilirubinemia; iInclusion criteria are gestational age above 37 weeks and absence of other concomittant diseases such as hemolysis and upper limit of their bilirubin are 18 mg/dl.
Age
From 3 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
National Committee for Ethics in Biomedical Research
Street address
The headquarters of the Ministry of Health and Medical Education-Sharak Gharb - Tehran
City
Tehran
Postal code
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
66001089/27
Health conditions studied
1
Description of health condition studied
Icter
ICD-10 code
R17
ICD-10 code description
P55-59
Primary outcomes
1
Description
Bilirubin
Timepoint
pretreatment and 6 hours after phototherapy
Method of measurement
blood sampling
2
Description
melatonin
Timepoint
after depletion of bilirubin
Method of measurement
special kit and blood sampling
Secondary outcomes
1
Description
kernicterus
Timepoint
during of treatment
Method of measurement
sign and symptoms
2
Description
complications
Timepoint
at the end of treatment
Method of measurement
observation
3
Description
duration of phototherapy
Timepoint
at the end of treatment
Method of measurement
observation
4
Description
hospital lenght of stay
Timepoint
at the end of treatment
Method of measurement
observation
5
Description
melatonin
Timepoint
at the end of treatment
Method of measurement
blood sampling
Intervention groups
1
Description
Continuous phototherapy for control group
Category
Treatment - Other
2
Description
Intermittent phototherapy for intervention group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hosoital
Full name of responsible person
Dr Taheri
Street address
Loghman hosoital, Lashkar cossing, South Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Loghman Hospital
Full name of responsible person
Dr. Hasan Peyvandi
Street address
Loghman Hospital, Lashgar Cross. South Kargar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?