A clinical trial comparing the effects of two different brands of ibuprofen (Pedea and Ibuprofen) on ductus arteriosus closure in premature infants with patent ductus arteriosus
Comparing the effects of two different brands of ibuprofen (Pedea and Ibuprofen) on ductus arteriosus closure in premature infants with patent ductus arteriosus
Design
Two-arm paralleled phase 3 trial without blinding and randomization.
Settings and conduct
A non-blinded study will be conducted in the pediatric department of Valiasr Hospital in Birjand. One group will receive Pedea, the French brand of ibuprofen produced by Orphan pharmaceutical company, while the other group will receive the Iranian form of ibuprofen, which is a generic version produced by Caspian Tamin Pharmaceutical Company. Both groups will receive intravenous injections of the medicine. The first day's dose will be 10 mg/kg, followed by 5 mg/kg after 24 hours, and another 5 mg/kg 24 hours later. The study will involve 160 patients who will be divided into two groups, with the first 80 receiving intervention from Group 1 and the subsequent 80 receiving intervention from Group 2.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Preterm newborn and size of patent ductus arteriosus that responds to drug therapy. Major exclusion criteria: the presence of underlying heart diseases, major congenital anomalies, and life-threatening sepsis.
Intervention groups
Intervention group 1 (French Ibuprofen): Ibuprofen from the French pharmaceutical company ORPHAN, Pedea brand, will be injected intravenously at doses of 10 mg/kg on the first day, 5 mg/kg 24 hours later, and 5 mg/kg 24 hours later (the last dose).
Intervention group 2 (Iranian Ibuprofen): Ibuprofen from the Iranian Caspian Tamin Pharmaceutical Company, under the Ibuprofen generic name, will be injected intravenously at doses of 10 mg/kg on the first day, 5 mg/kg 24 hours later, and 5 mg/kg 24 hours later (the last dose).
Main outcome variables
Ductus arteriosus closure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N48
Registration date:2023-05-15, 1402/02/25
Registration timing:prospective
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effects of two different brands of ibuprofen (Pedea and Ibuprofen) on ductus arteriosus closure in premature infants with patent ductus arteriosus
Public title
Effects of two different brands of ibuprofen on ductus arteriosus closure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm newborn
A size of patent ductus arteriosus that responds to drug therapy
Gestational age of 32 weeks or more
Birth weight 1500 grams and less
Age between 3 and 15 days
Exclusion criteria:
Presence of underlying heart diseases
Major congenital anomalies
Life-threatening sepsis
Renal failure
Pulmonary hemorrhage
Thrombocytopenia below 60,000/mm3
Age
From 3 days old to 15 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
Ir.bums.REC.1397.325
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
Ductus arteriosus closure
Timepoint
Prior to treatment initiation and three days post-treatment completion
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (French Ibuprofen/Pedea): Ibuprofen from the French pharmaceutical company ORPHAN, Pedea brand, will be injected intravenously at doses of 10 mg/kg on the first day, 5 mg/kg 24 hours later, and 5 mg/kg 24 hours later (the last dose).
Category
Treatment - Drugs
2
Description
Intervention group 2 (Iranian Ibuprofen): Ibuprofen from the Iranian Caspian Tamin Pharmaceutical Company, under the Ibuprofen generic name, will be injected intravenously at doses of 10 mg/kg on the first day, 5 mg/kg 24 hours later, and 5 mg/kg 24 hours later (the last dose).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital's Pediatrics Department
Full name of responsible person
Alireza Taghizadegan
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3223 1580
Email
taghizadem98@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research, Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Miri
Street address
Vice-chancellory for Research, Birjand University of Medical Sciences, Ayatollah Ghafari Street,
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 5600
Email
Miri_moh2516@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Alireza Taghizadegan
Position
General Practirtioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3223 1580
Email
taghizadem98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Forud Salehi
Position
Pediatric cardiologist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3240 9583
Email
salehiforod@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3244 0447
Email
mbroozgar@bums.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
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set and other information related to research methodology
When the data will become available and for how long
After the paper extracted from the project is published and for 6 months ever since
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Personal email to the corresponding author of the extracted article