Efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates
Design
The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized
Settings and conduct
The aim of this study was to investigate the efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates in the specialty clinic of Heshamateyeh Hospital in Sabzevar city. In this study, the clinical observant and participants will be unaware of how children are grouped. Children are randomly assigned to the intervention (Ursodeoxycholic acid capsule and phototherapy) and the control (phototherapy) group. The response to treatment will be evaluated by measuring total bilirubin levels at 12, 24, and 36 after starting the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The Birth weight more than 2500 gr, Gestational age more than 37 weeks, The birthday more than 2 days and less than two weeks, The Total bilirubin level is 14-20 mg/dl and the direct bilirubin level is less than2 mg/dl، No Septicemia, lack of Crigler–Najjar syndrome, Thyroid, and liver disease، lack of direct hyperbilirubinemia, Incompatibility of blood group and RH، lack of G6PD deficiency.
Exclusion criteria: Parental dissatisfaction for any reason، The incidence of any side effects of Ursodeoxycholic acid, Infants from diabetic mother
Intervention groups
Intervention group: Patients in this group are treated by phototherapy and capsules of Urosobil (manufactured by Alborz Pharmaceuticals and dissolved in 10 cc infant milk) at 10 mg/kg daily for two days.
Control group: Patients in this group only are treated by phototherapy for two days.
Main outcome variables
Total bilirubin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170719035178N2
Registration date:2019-02-10, 1397/11/21
Registration timing:registered_while_recruiting
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Mitra Aldaghi
Name of organization / entity
Sabzevar University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 514411071
Email address
aldaghim@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of Ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy
Public title
Efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weight more than 2500 gr
Gestational age more than 37 weeks
The birthday more than 2 days and less than two weeks
The total bilirubin level is 14-20 mg/dl and the direct bilirubin level is less than 2 mg/dl
No Septicemia
lack of Crigler–Najjar syndrome
lack of Thyroid disease
lack of Liver disease
lack of direct hyperbilirubinemai
Incompatibility of blood groups and RH
lack of G6PD deficiency
Infants aged 2 to 14 days
Exclusion criteria:
Parental dissatisfaction for any reason
The incidence of any side effects of Ursodeoxycholic acid
Infants from diabetic mother
Age
From 2 days old to 14 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on permutation. Accordingly, 22 blocks are allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, group A is treated with Phototherapy and Ursodeoxycholic acid capsule and Group B is treated with Phototherapy.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The clinician and practitioner are unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.MEDSAB.REC.1397.042
Health conditions studied
1
Description of health condition studied
Indirect Hyperbilirubinemia
ICD-10 code
P58.9
ICD-10 code description
Neonatal jaundice due to excessive hemolysis, unspecified
Primary outcomes
1
Description
Total bilirubin
Timepoint
The time intervals for measuring total bilirubin levels are at the baseline (before the intervention), 12, 24, and 36 hours after starting treatment (phototherapy with or without Ursobil).
Method of measurement
Autoanalyzer devices
Secondary outcomes
1
Description
Drug side effects
Timepoint
During the intervention at 12, 24, and 36 hours after intervention
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: Patients in this group are treated by phototherapy and capsules of Urosobil (manufactured by Alborz Pharmaceuticals and dissolved in 10 cc infant milk) at 10 mg/kg daily for two days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group are treated by phototherapy for two days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatiyeh hospital
Full name of responsible person
Najmeh Mehri
Street address
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
mehri.najmeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitrah Aldaghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4411 1071
Email
Aldaghim@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitrah Aldaghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 514411071
Email
Aldaghim@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Najmeh Mehri
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4493 3565
Email
mehri.najmeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available