This is a randomized clinical trial to determine the efficacy of ursobil and phototherapy in decreasing neonatal hyperbilirubinemia. One hundred twenty neonates at ages 3-15 days with gestation ages more than 35 weeks who admitted for non-hemolytic neonatal jaundice, randomly allocate in three groups (each group 40 cases).
In group A, neonates receive ursobil 10mg/kg in addition to phototherapy. Neonates in group B receive 15 mg/kg ursobil in addition to phototherapy.
Patients in group C receive water and photo therapy.We evaluate and compare the rate of bilirubin decrease, the stool context (diarrhea, constipation), and other complications such as vomiting, feeding intolerance in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701313915N18
Registration date:2017-02-11, 1395/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
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
Evaluating the efficacy of ursodesoxy colic acid (ursobil) in reducing total serum bilirubin
Public title
Evaluating the efficacy of ursobil in reducing bilirubin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weight more than 2500 grams; gestation age more than 35 weeks; age above 3 days less than 2 weeks; total serum bilirubin 14-20 mg/dl; direct bilirubin less than 2 mg/dl.
Exclusion criteria:
ABO incompatibility; Rh immunization; G6PDdefficiency; direct hyperbilirubinemia; sepsis; Crigler-Najjar syndrome; thyroid disorders; hepatic diseases; prematurity; infant of diabetic mother
.
Age
From 3 days old to 15 days old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of TabrizUniversity ofMedical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2016-12-05, 1395/09/15
Ethics committee reference number
IR.TBZMED.REC.1395.928
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
The rate of bilirubin decrease
Timepoint
6,12,24 and 48 hours after starting treatment
Method of measurement
Measurment of total serum bilirubin
Secondary outcomes
1
Description
The duration of hospitalization
Timepoint
From admission til discharge
Method of measurement
The hours and days of admission
Intervention groups
1
Description
Internention group A recieve
dissolved oral ursobil 10mg/kg in addition to phototherapy
Category
Treatment - Drugs
2
Description
Intervention group B recieve
dissolved oral ursobil 15mg/kg in addition to phototherapy
Category
Treatment - Drugs
3
Description
Control group recieve
water plus phototherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afsane Mokhaleg Sani
Position
resident of pediatrics
Other areas of specialty/work
Street address
Sheshgelan street
City
Tabriz
Postal code
Phone
+98 41352662257
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Mostafa Gharehbaghi. M.D.
Position
Professor of Pediatrics
Other areas of specialty/work
Street address
Sheshgelan street
City
Tabriz
Postal code
Phone
+98 41352662257
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afsane Mokhaleg Sani. M.D.
Position
Other areas of specialty/work
Street address
Sheshgelan street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)