A comparative study on efficacy of ursodeoxycholic plus phototherapy with single phototherapy in the treatment of indirect hyperbilirubinemia of neonates
The main goal in this study is to consider the efficacy of ursodeoxycholic plus phototherapy in the treatment of indirect hyperbilirubinemia of neonates in comparison with single phototherapy. 100 newborns will be enrolled in the study and will be randomly divided into two groups.
Inclusion criteria: Birth weight between 2500 to 4000 g; Only breastfeeding; Gestational age between 38 to 41 weeks; Older than 3 days, total bilirubin between 14 to 20 mg/dL; direct bilirubin less than 2 mg/dL.
Exclusion criteria: ABO and RH incompatibility; G6PD Deficiency; Direct hyperbilirubinemia; Septicemia; diseases leading to hyperbilirubinemia; Premature infants; Newborns of diabetic mothers.
This is a double blind study namely both the subjects participating and the researchers will be unaware of medication type. The treatment group (n=50) will receive 10 mg/kg/day divided q12h ursodeoxycholic acid in addition to phototherapy, while the control group (n=50) will receive just phototherapy. Total bilirubin levels will be measured every 12 hours until reaching below 10mg/dL. Also, duration of phototherapy and hospitalization in both groups will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611163127N3
Registration date:2016-12-31, 1395/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-31, 1395/10/11
Registrant information
Name
Mehrdad Mirzarahimi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 0399
Email address
mmirzarahimi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ardabil University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on efficacy of ursodeoxycholic plus phototherapy with single phototherapy in the treatment of indirect hyperbilirubinemia of neonates
Public title
efficacy of ursodeoxycholic plus phototherapy in the treatment of neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Birth weight between 2500 to 4000 g; Only breastfeeding; Gestational age between 38 to 41 weeks; Older than 3 days, total bilirubin between 14 to 20 mg/dL; direct bilirubin less than 2 mg/dL.
Exclusion criteria: ABO and RH incompatibility; G6PD Deficiency; Direct hyperbilirubinemia; Septicemia; diseases leading to hyperbilirubinemia (including Crigler-Najjar syndrome, Gilbert's syndrome, hypothyroidism / hyperthyroidism, liver diseases, and ....); Premature infants; Newborns of diabetic mothers.
Age
From 3 days old to 28 days old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomizing with Closed Packet Method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Street, Ardabil.
City
Ardabil
Postal code
5618985991
Approval date
2015-10-23, 1394/08/01
Ethics committee reference number
IR.ARums.REC.1394.88
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P58, P59
ICD-10 code description
Neonatal jaundice due to other excessive haemolysis, Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
total bilirubin
Timepoint
on admission and every 12 hours after admission until discharge
Method of measurement
Blood sampling
2
Description
time duration in which bilirubin levels reaches to normal level
Timepoint
Continuously (from treatment beginning until bilirubin reach to normal levels)
Method of measurement
Timer
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention Group: Phototherapy (with 8-lamp Phototherapy unit made by Tousan Company; Tehran, Iran) along with 10 mg/kg/day divided q12h ursodeoxycholic acid (made by Dr. Adidbi Company; Tehran, Iran).
The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL.
Category
Treatment - Drugs
2
Description
Control Group: Phototherapy (with 8-lamp Phototherapy unit made by Tousan Company; Tehran, Iran) along with water as placebo.
The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Shima Sarfarazi
Street address
Bu Ali Hospital, Saheli Street, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah Street, Ardabil
City
Ardabil
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, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Shima Sarfarazi
Position
Medical Resident
Other areas of specialty/work
Street address
Bu-Ali Hospital, Saheli street, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 3373 1210
Fax
-
Email
sh.sarfarazi@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences.
Full name of responsible person
Dr Mehrdad Mirzarahimi
Position
Pediatrics Specialist
Other areas of specialty/work
Street address
Bu-Ali Hospital, Saheli Street, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 3373 1210
Fax
-
Email
mehrdadmirzarahimi@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shima Sarfarazi
Position
Medical Resident
Other areas of specialty/work
Street address
Bu-Ali Hospital, Saheli street, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 3373 1210
Fax
-
Email
sh.sarfarazi@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)