Determination the Effect of oral Ursodeoxycholic acid with phototherapy on indirect hyperbilirubinemia in glucose-6-phosphate dehydrogenase-deficient neonates
Design
Clinical trial with control group, with 3 parallel groups, single-blinded, and randomized
Settings and conduct
The neonates who admit to the neonatal ward, randomly assigned to intervention group one and two, will receive Ursodeoxycholic acid manufactured by Koushan-Farma Co., Tehran, soluted in breast milk with two different doses, by a nurse as open label. The control group will receive the same amount of breast milk as placebo. The neonatologist, who evaluates the outcome in three groups, is blind to the study groups.
Participants/Inclusion and exclusion criteria
The 2 to 14 days-old neonates whose total bilirubin levels are in the range of phototherapy according to the neonatal phototherapy curve and need to be hospitalized and have glucose 6-phosphate dehydrogenase deficiency (G6PD) after diagnostic investigation . Neonates requiring exchange transfusion do not enter the study
Intervention groups
1.Group 1: neonates receiving phototherapy and Ursodeoxycholic acid (10 mg / kg / day every 12 hours to 48 hours).
2.Group 2: neonates receiving phototherapy and Ursodeoxycholic acid (20 mg / kg / day every 12 hours to 48 hours).
3.Control group: neonates receiving phototherapy and placebo (breast milk equal to volume of diluted drug in milk for 48 hours
Main outcome variables
Mean of total serum bilirubin at 12, 24,48 and 72 hours after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091201002801N4
Registration date:2019-06-15, 1398/03/25
Registration timing:prospective
Last update:2019-06-15, 1398/03/25
Update count:0
Registration date
2019-06-15, 1398/03/25
Registrant information
Name
Roya Farhadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3018
Email address
rfarhadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Ursodeoxycholic acid with phototherapy on indirect hyperbilirubinemia in glucose-6-phosphate dehydrogenase-deficient neonates
Public title
Effect of oral Ursodeoxycholic acid on indirect jaundice of glucose-6-phosphate dehydrogenase-deficient neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Exclusive breast fed neonates
Neonates with age of 2-14 days
Direct bilirubin less than 15% of total serum billirubin or less than 1.5 mg/dl
Neonates weighing between 2500 to 4000 grams.
Neonates with jaundice and glucose 6-phosphate dehydrogenase deficiency require admission and phototherapy.
Exclusion criteria:
Neonates with sepsis diagnosis
Blood group or Rh incompatibility between mother and neonate
Direct hyperbilirubinemia
Major congenital anomalies
Need to exchange transfusion at the time of admission
previous use of drugs like phenobarbital or cotoneaster
History of previous exchange transfusion
Previous phototherapy
Infants of diabetic mother
Spherocytosis or elliptocytosis in peripheral blood smear
Evidence of severe hemolysis, Retic≥5%
Age
From 2 days old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of individuals by use of table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Neonatologist who will investigate the bilirubin level and will asses the outcome is blind about the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.MAZUMS.REC.1398.222
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes
Primary outcomes
1
Description
Mean total serum bilirubin level based on Mg/dl
Timepoint
12, 24, 48 and 72 hours after intervention
Method of measurement
With the Diazo method and the kits of Tehran Pars َAzmoon Co.
Secondary outcomes
1
Description
The percentage of total serum bilirubin reduction to the initial bilirubin
Timepoint
24 hours after admission
Method of measurement
With the Diazo method and the kits of Tehran Pars Azmoon Co.
2
Description
Duration of phototherapy
Timepoint
At discharge time
Method of measurement
Phototherapy's timer to hour
3
Description
Duration of admission
Timepoint
At discharge time
Method of measurement
Patient's file observation and documantation
4
Description
Duration of intensive phototherapy
Timepoint
At discharge time
Method of measurement
Patient's file observation and documantation
5
Description
Need to exchange
Timepoint
During admission
Method of measurement
Patient's file observation and documantation
6
Description
Need to re-hospitalization after discharge
Timepoint
14 days of life
Method of measurement
Patient's file observation and documantation
7
Description
The necessary time in which, first total serum bilirubin level reaches to less than 10mg/d
Timepoint
During admission
Method of measurement
Patient's file observation and documantation
Intervention groups
1
Description
Intervention group 1: Neonates receiving phototherapy and Ursodeoxycholic acid (10 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk .
Category
Treatment - Drugs
2
Description
Intervention group 2: Neonates receiving phototherapy and Ursodeoxycholic acid (20 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk .
Category
Treatment - Drugs
3
Description
Control group: Neonates receiving phototherapy and placebo (breast milk).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali-Sina Hospital
Full name of responsible person
Roya Farhadi
Street address
Pasdaran bulevard-Boo Ali-Sina Hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
dr.royafarhadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3324 1906
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Booali hospital. Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Booali hospital. Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bouali Sina hospital, Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Getting written permission for any use of data
From where data/document is obtainable
Sending message to Dr. Roya Farhadi by E-mail:
dr.royafarhadi@gmail.com
What processes are involved for a request to access data/document
After E-mail, information is sent within a few days.