Hyperbilirubinemia is a common problem during infancy.Typically, phototherapy is used for reducing bilirubin in neonates; however, it has disadvantages.Therefore, the present study aims to investigate the effect of ursodeoxycholic acid on reducing the indirect bilirubin of the infants undergoing phototherapy; so that their lengths of phototherapy and hospitalization can be reduced.
The present randomized clinical trial was conducted on the infants with hyperbilirubinemia who were under treatment by phototherapy in the neonatal wards of the hospitals affiliated to Shiraz University of Medical Sciences, Shiraz ,IRAN. Study design is interventional, randomaized, single blind.The infants are randomly divided into two 40-subject. The first group which include 40 infants with hyperbilirubinemia receive 10-15 mg/kg/day q12h ursodeoxycholic acid, while the control group receive no medications and only underwent phototherapy. The inclusion criteria of the study are birth weight of 2500-4000 g; being exclusively breast fed; gestational age of 38-41 weeks; being above 3 days old; total bilirubin level of 14-20, and direct bilirubin level<2 mg/dL.
On the other hand, the infants with hemolysis & septicemia and the infants of diabetic mothers exclude from the study. Indirect bilirubin levels measure 2 time per day until the bilirubin level reache below 10 and phototherapy disrupte. The length of phototherapy measure using a timer. Finally the two groups are compared from the time bilirubin reache below 10, and length of phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020512370N1
Registration date:2013-05-12, 1392/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Narjes Pishva
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 0182
Email address
ghashghaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective study on The additive effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy
Public title
A prospective study on The additive effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: birth-weight 2500-4000 gr; gestational age between 38-41 weeks; breastfeeding neonate; total bilirubin 14-20 mg/dl and neonates age older than three days.
Exclusion criteria: infants with incompatible ABO, Rh; G6PD deficiency; direct hyper billirubinemia; septicemia or diseases that are implicated in causing jaundice; premature infants; infants of diabetic mothers.
Age
From 3 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical science
Street address
shiraz university of medical scienc,zand street,shiraz
City
shiraz
Postal code
71438-14336
Approval date
2012-09-20, 1391/06/30
Ethics committee reference number
CT-P-91-3827
Health conditions studied
1
Description of health condition studied
Indirect hyperbilirubinemia in neonate
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Duration of need phototherapy
Timepoint
Since start study till finish study
Method of measurement
Timer
Secondary outcomes
1
Description
Serum total bilirubin
Timepoint
Since start study &12, 24, 36, 48 hour
Method of measurement
Blood sample
Intervention groups
1
Description
First group was given ursodeoxycholic acid 10-15 mg/kg divided q12h before starting phototherapy till exclusion from study. In the first day, laboratory tests included estimation of total bilirubin (direct and indirect), blood group including rh of the mother and neonate, complete blood count (cbc), g6pD activity, coombs test, reticulocyte count. Direct and indirect, as well as tsb were measured every 24 hours by the same laboratory till total serum bilirubin dropped under 10 mg/dl. The duration of phototherapy was recorded with a timer.
Category
Treatment - Drugs
2
Description
Second group that is control group received no medications and only underwent phototherapy.