Determination of the effect of oral Ibuprofen in term Infants with Patent Dactus Arteriosus (PDA)
Design
This study is a clinical trial with a control group, parallel groups, double-blinded and randomized.
Settings and conduct
This study is done in Imam Ali clinic in Shahrekord.40 term infants randomly assign to two groups of 20 and Intervention is done . echocardiography is performed on the day of 7 after intervention,and neonates are evaluated for pda closure.infants assignment is done by the secretary and physician doing echocardiography is not aware of the allocation of infants to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Gestational age more than 37 weeks. age between 5 and 30 days old. PDA size more than 1.5 mm detected by echocardiography.
Exclusion criteria: having ductal dependent congenital heart disease, creatinine more than 88.5 micromol/l, platelet count less than 50000.
Intervention groups
Intervention group: reciving Ibuprofen, as an oral aqueous suspension (100 mg/5 ml;Alborz pharmaceutical) with a dose of 10 mg/kg at the beginning and four doses of 5 mg/kg with 24 hours intervals
Control group: reciving no drug.
Main outcome variables
Closure of Patent dactus arteriosus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190204042618N1
Registration date:2019-02-15, 1397/11/26
Registration timing:registered_while_recruiting
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
najme bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 8235
Email address
st_bagherin@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
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
The Effect of oral Ibuprofen in term Infants with Patent Dactus Arteriosus
Public title
The effects of Ibupropen on term infants arterial duct
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age more than 37 weeks
Age between 5 and 30 days old
Patent dactus arteriosus size more than 1.5 mm detected by echocardiography
Exclusion criteria:
Having ductal dependent congenital heart disease
Creatinine more than 88.5 micromol/l
Platelet count less than 50000
Age
From 5 days old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,The assignment of infants to these two groups is done in such a way that the infants parents choose a card from 40 colored cards that are designed in two different colors and according to the chosen color the infant goes to one of the two groups (Each card belongs to one of the study cases.)
Blinding (investigator's opinion)
Double blinded
Blinding description
After conducting echocardiography and confirming the presence of Patent dactus arteriosus by the doctor, infant's parents go to the secretary and By choosing a card, they randomly go to one of the two groups of interventions.Then the secretary Based on the relevant group, gives the
infant's parent ibuprofen susp and explains how and how much it is consumed or dose not give any drug .she records the required information in the list. Also in reoccurrence to examine the closure of the arterial duct, echo results recorded by the secretary in the previous checklist. So the doctor, who evaluates the ductus arteriosus closure does not know the allocation of newborns to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.SKUMS.REC.1397.091
Health conditions studied
1
Description of health condition studied
Patent Dactus Arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
Patent Dactus Arteriosus closure
Timepoint
Day one, Day 7 after intervention
Method of measurement
Eco cardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: reciving Ibuprofen, as an oral aqueous suspension (100 mg/5 ml;Alborz pharmaceutical) with a dose of 10 mg/kg at the beginning and four doses of 5 mg/kg with 24 hours intervals
Category
Treatment - Drugs
2
Description
Control group: reciving no drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Dr. Nabi Allah Asadpour
Street address
Imam Ali Clinic.,Shariati Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
N.ASADPOUR@SKUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Nabi Allah Asadpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 8235
Email
n.asadpour@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Nabi Allah Asadpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
N.asadpour@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Nabi Allah Asadpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
N.asadpour@skums.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
Yes - There is 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
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete studies
From where data/document is obtainable
Hajar Hospital in Shahrekord
What processes are involved for a request to access data/document
after the investigation of resercher request and presentation of required documents will be accessible.