Effect of intravenous ibuprofen versus intravenous paracetamol on the occlusion of patent ductus arteriosus in preterm infants: a single-blind randomized clinical trial
To assess the effect of intravenous ibuprofen versus intravenous paracetamol on the occlusion of patent ductus arteriosus in preterm infants
Design
This is a single-blind randomized clinical trial, phase II, in which 50 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible preterm infants with patent ductus arteriosus will refer to Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group. This trial will be single-blinded so that infants will be not aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gestational age equal to or less than 37 weeks,
The past time after birth equal to or less than 14 days,
Patent ductus arteriosus
Exclusion criteria:
Infectious disease,
Hyperbilirubinemia needing transfusion,
Active necrotizing enterocolitis or intestinal perforation,
Liver function disorder,
Any hemorrhagic disorder,
Retinopathy,
Bronchopulmonary dysplasia,
Platelet deficiency
Intervention groups
Intervention group:
Intravenous ibuprofen (manufactured by Caspian Tamin Pharmaceutical Company) first 10 mg/kg then 5 mg/kg every 12 hours for 3 days
Control group:
Intravenous paracetamol (manufactured by Caspian Tamin Pharmaceutical Company) 15 mg/kg every 6 hours for 3 days
Main outcome variables
Primary outcome:
The occlusion of patent ductus arteriosus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N321
Registration date:2019-12-10, 1398/09/19
Registration timing:registered_while_recruiting
Last update:2019-12-10, 1398/09/19
Update count:0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-24, 1398/09/03
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous ibuprofen versus intravenous paracetamol on the occlusion of patent ductus arteriosus in preterm infants: a single-blind randomized clinical trial
Public title
Effect of intravenous ibuprofen versus intravenous paracetamol on the occlusion of patent ductus arteriosus in preterm infants: a single-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age equal to or less than 37 weeks,
The past time after birth equal to or less than 14 days,
Patent ductus arteriosus
Exclusion criteria:
Infectious disease,
Hyperbilirubinemia needing transfusion,
Active necrotizing enterocolitis or intestinal perforation,
Liver function disorder,
Any hemorrhagic disorder,
Retinopathy,
Bronchopulmonary dysplasia,
Platelet deficiency
Age
From 1 day old to 14 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The infants will be unaware of the type of intervention. Thus, the trial will be run as single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398.675
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
The occlusion of patent ductus arteriosus
Timepoint
Three days after that
Method of measurement
Through echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous ibuprofen (manufactured by Caspian Tamin Pharmaceutical Company) first 10 mg/kg then 5 mg/kg every 12 hours for 3 days
Category
Treatment - Drugs
2
Description
Control group: Intravenous paracetamol (manufactured by Caspian Tamin Pharmaceutical Company) 15 mg/kg every 6 hours for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Mayam Zeinali
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
parisazeinali@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mayam Zeinali
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
parisazeinali@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Kazem Sabzei
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mk_sabzehei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available