Evaluating the effect of ursodeoxycholic acid in reducing hospitalization for intensive phototherapy in neonates with indirect hyperbilirubinemia referred to outpatient clinics in comparison with the control group
Investigate the effect of Ursodioxycholic acid (UDCA) in reducing hospital admission rate for intensive phototherapy in neonate with indirect hyperbilirubinemia
Design
This is a clinical trial study phase 3 in neonates with hyperbilirubinemia which performs in two parallel groups receiving drug and placebo. The study is a triple blind, block randomized design. The sample size is calculated to be 148.
Settings and conduct
The study is performed on neonate with jaundice who are brought to Imam Reza , Hazrat Zeinab or Hafez outpatient clinics in Shiraz. Caregivers, physicians, and data analysts are not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Neonates with a bilirubin between 3 mg / dL less than required for intensive phototherapy and the level required for intensive phototherapy in hospital participate in this study. All of these neonates need phototherapy at home. Other inclusion criteria: neonate with gestational age 35 weeks or more, exclusive breastfeeding, age over one day and direct bilirubin below 2 mg / dL . Exclusion criteria: Blood incompatibility, cardiac or liver disease , infection and sepsis or infant of diabetic mother
Intervention groups
Ursodioxycholic acid suspension (prepared from 300 mg capsule of Alborz Darou Pharmaceutical Co. as a suspension of 60 mg / 1cc) prescribe orally as 10 mg /kg body weight of the neonate, divided into 2 doses every 12 hours . At the same intervals, the control group is given the same volume of placebo. Both groups receive medication or placebo until their bilirubin drops below 3 units less than intensive phototherapy level.
Main outcome variables
Hospitalization rate for intensive phototherapy; Total bilirubin; Medication side effects (nausea, vomiting, skin rash)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190604043813N4
Registration date:2021-06-21, 1400/03/31
Registration timing:prospective
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Hourvash Akbari Haghighinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4967
Email address
hhaghighi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of ursodeoxycholic acid in reducing hospitalization for intensive phototherapy in neonates with indirect hyperbilirubinemia referred to outpatient clinics in comparison with the control group
Public title
Effect of ursodeoxycholic acid in reducing hospitalization for phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Exclusive breastfeeding,
Age above 1 day
Neonate born with gestational age 35 weeks or more
Total bilirubin between 3 mg / dL less than the level required for intensive phototherapy treatment in the hospital and the level required for hospitalization
Direct bilirubin levels below 2 mg / dL.
Parent consent
Infants whose parents agree not to use herbal or traditional medicines during the study period.
Exclusion criteria:
Rh incompatibility
Uunderlying disease such as heart and liver disease
Infection and septicemia
Neonate of diabetic mother
Age
From 2 days old to 15 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
148
More than 1 sample in each individual
Number of samples in each individual:
3
Total bilirubin
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization list with block size of 4 generates by https://www.sealedenvelope.com/simple-randomiser/v1/lists.The sample size , size of blocks and study groups are given to the system, and the system determines the order of the blocks and the order in each block in a list. The drug and placebo are arranged in a box according to the list by a pharmacist and are given to a doctor who is responsible for the research to be given to the neonates.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo which are prepared in syrup and are distinguishable by A and B labels will be arrange in a box according to the randomization list by the pharmacist who has no responsibility for patients care . The box will be given to a doctor who is unaware of the intervention type and he give the treatment in specified order . Caregivers, physicians are not aware of the treatment. The results are compiled and analyzed by a statistician who is not aware of the intervention type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research of Shiraz Medical School
Street address
ّFamily medicine department , Namazi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7184983858
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.SUMS.MED.REC.1400.076
Health conditions studied
1
Description of health condition studied
Neonatal indirect hyperbilirubinemia
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Hospitalization rate
Timepoint
Weekly, from week 1 to 4 after the start of the intervention
Method of measurement
Asking the parents about admission in hospital for phototherapy
Secondary outcomes
1
Description
Total bilirubin
Timepoint
Every 24 hours until the bilirubin reaches 3 mg / dl below the level required for intensive phototherapy
Method of measurement
Capillary method and diazo laboratory method
2
Description
Adverse effect of drug
Timepoint
Till 4 weeks after the start of the drug
Method of measurement
Asking the parents about adverse effect
Intervention groups
1
Description
Intervention group:The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (1/6cc/kg) daily divided into 2 doses every 12 hours. UDCA 300 mg capsule(provided by Alborz Darou Company, Tehran, Iran) is used for the preparation of 60 mg/1cc suspension. Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy.
Category
Treatment - Drugs
2
Description
Control group: At 12 hours intervals, the control group received the same volume placebo suspension (1/6cc/kg). Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Mehrdad Rezaie
Street address
Zand street. Nemazi Square.
City
Shiraz
Province
Fars
Postal code
7184983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
hhaghighi@sums.ac.ir
2
Recruitment center
Name of recruitment center
Clinic of Hafez hospital
Full name of responsible person
Mehrdad Rezaie
Street address
Abiverdi Blvd.
City
Shiraz
Province
Fars
Postal code
7184983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
md_rezaie@yahoo.co.uk
3
Recruitment center
Name of recruitment center
Clinic of Zeinabiye Hospital
Full name of responsible person
Mehrdad Rezaie
Street address
Sibuye Blvd.
City
Shiraz
Province
Fars
Postal code
7184983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
md_rezaie@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7194983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hourvash Akbari Haghighinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Family Medicine Department, Namazi Hospital, Zand Street,
City
Shiraz
Province
Fars
Postal code
7194983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
hhaghighi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hourvash Akbari Haghighinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Family Medicine Department, Namazi Hospital, Zand Street,
City
Shiraz
Province
Fars
Postal code
7194983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
hhaghighi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hourvash Akbari Haghighinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Zand street, Namazi hospital, Family medicine department
City
Shiraz
Province
Fars
Postal code
7184983858
Phone
+98 71 3647 4967
Fax
+98 71 3647 4967
Email
hhaghighi@sums.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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the publication of the main article, all collected de-identified IPD can be shared.
When the data will become available and for how long
From the time of publication until 6 months later
To whom data/document is available
All people who request to access the documents
Under which criteria data/document could be used
After the publication of the main article, if the source of the main study is mentioned, the data will be available for systematic review and meta-analysis.
From where data/document is obtainable
hhaghighi@sums.ac.ir
What processes are involved for a request to access data/document
The request can be sent to the email adress mentioned above