Jaundice is a common problem during neonatal period.The aim of this study is to evaluate the effect of ursodeoxycholic acid on breast milk jaundice. This study is a double-blind, randomized clinical trial that is conducted on neonates with breast milk jaundice (inpatient or outpatient) in hospitals affiliated to Shiraz University of Medical Sciences in 2017 that treat with phototherapy. Infants are randomly divided into two groups of 40, the patient group treat with phototherapy (home or hospital) and Ursobil 10 mg/kg/day (capsule 300 mg) orally divides every 12 hours. The drug is given to them by a pharmacist. The control group include 40 infants who receive placebo (distilled water) and phototherapy (home or hospital). Total bilirubin level is measured 12, 24 and 48 hours after phototherapy until bilirubin levels fall below 12 and phototherapy is discontinued. Two groups are compared in terms of total bilirubin levels at different times and during phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013028154N1
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Nader Shakibazad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 3731
Email address
shakibn@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective study on the effect of ursodeoxycholic acid on breast milk jaundice in neonate
Public title
Effect of ursodeoxycholic acid on breast milk jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: birth weights 2500 to 4000 gram; being exclusively breastfed; gestational age of 38 to 41 weeks; age more than 7 days old; total bilirubin level of 14 to 20 mg/dL; direct bilirubin level less than 2 mg/dL. Exclusion criteria: infants with ABO and RH incompatibility; glucose 6-phosphate dehydrogenase deficiency; direct hyperbilirubinemia; septicemia; diseases leading to hyperbilirubinemia (Crigler-Najjar syndrome, gilbert syndrome, hypothyroidism and hyperthyroidism, liver diseases, premature neonates and the infants of diabetic mothers)
Age
From 7 days old to 1 month old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The method of randomization is the four-block method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street, Central building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
94-01-01-8985
Health conditions studied
1
Description of health condition studied
Breast milk jaundice
ICD-10 code
P59.3
ICD-10 code description
Neonatal jaundice from breast milk inhibitor
Primary outcomes
1
Description
Total bilirubin level
Timepoint
Before intervention, 12, 24 and 48 hours after intervention
Method of measurement
mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Intervention group includes 40 neonates with breast milk jaundice that treat with phototherapy (home or hospital) and URSODEOXYCHOLIC ACID 10 mg/kg/day (CAPSULE ORAL 300 mg) orally divides every 12 hours. The drug is given to them by a pharmacist. Total bilirubin level is measured 12, 24 and 48 hours after phototherapy until bilirubin levels fall below 12 and phototherapy is discontinued. Two groups are compared in terms of total bilirubin levels at different times and duration of phototherapy. Written informed consent is taken from patients before the study. The URSODEOXYCHOLIC ACID is in capsule form 300 mg from Pharmaceutical Co. Alborz Darou. The drug is given to neonate by a pharmacist in a dose of 10 mg/kg divided two times in a day and there is no interaction between feeding and this drug.
Category
Treatment - Drugs
2
Description
Control group:
The control groups include 40 infants who receiving placebo (distilled water) and phototherapy (home or hospital). Total bilirubin level is measured 12, 24 and 48 hours after phototherapy until bilirubin levels fall below 12 and phototherapy is discontinued. Two groups are compared in terms of total bilirubin levels at different times and duration of phototherapy. Written informed consent is taken from patients before study
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez, Nemazee and Zainebie hospitals of Shiraz University of Medical Sciences
Full name of responsible person
Maryam Nasri Lari
Street address
Nemazee hospital, department of neonatology, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi, Vice chancellor for research of Shiraz University of Medical Sciences
Street address
Zand Street, Research center, Central building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
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 of Shiraz University of Medical Sciences