The aim is evaluation effectiveness of Ibuprofen and Acetaminophen in closure of Patent Ductus Arteriosus
Design
This assessment is a clinical trial in Phase 4, newborns diagnosed with Patent Ductus Arteriosus that have been verified by echocardiography, are considered as study group. In this study, 80 children who meet the criteria are selected. Patients are categorized based on blocked randomization method, 40 children in the ibuprofen group and 40 children in the acetaminophen group. Accordingly, at the beginning of the diagnosis and 3 days after the start of treatment, the condition of the Patent Ductus Arteriosus is evaluated by echocardiography.
Settings and conduct
This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Infants less than 28 days of age referred to Amir Kabir Hospital, with Patent Ductus Arteriosus and without G6PD enzymatic defects, with physician approved and satisfactions of parents are enrolled to study. Also, children who are not willing to continue studying and also the neonates in case of congenital heart defects that Patent Ductus Arteriosus are life giving are excluded from the study.
Intervention groups
In the first group, the oral ibuprofen regimen (10 mg / kg / day) and in the second group oral acetaminophen regimen (7 mg / kg / day) are used, the duration of treatment for patients was three days from the start of treatment.
Main outcome variables
Patent Ductus Arteriosus Closure Status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013366N10
Registration date:2018-07-25, 1397/05/03
Registration timing:registered_while_recruiting
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Effectiveness of Ibuprofen and Acetaminophen in Closure of Patent Ductus Arteriosus
Public title
Effect of Ibuprofen and Acetaminophen in Cardiac Vessels of Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants less than 28 days old referring to Amir Kabir Hospital with Patent Ductus Arteriosus
Parental consent for participation in the study
No G6PD Enzymatic Deficiency
Exclusion criteria:
Dissatisfaction with using their information in the study
Neonates with congenital heart defects that Patent Ductus Arteriosus were life giving, such as pulmonary artery atresia, congenital or chromosomal major abnormalities, the history of using non-steroidal anti-inflammatory drugs during pregnancy by mother, the presence of Hydrops Fetalis, and a continuous increase in Pulmonary Blood Pressure.
Leaving the hospital with personal consent
Age
To 28 days old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, Accordingly, the patients under study are divided into two groups.
The allocation of patients in two groups was based on demographic characteristics and their matching.
Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.265
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
Patent Ductus Arteriosus Closure Status
Timepoint
Before intervention for diagnosis and within three days interval of starting the drug
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral ibuprofen ten milligrams per kilogram of body weight per day, for three days
Category
Treatment - Drugs
2
Description
Intervention group: Oral acetaminophen seven milligrams per kilogram of body weight per day, for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Maryam Beheshti Fard
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Beheshty1985@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Beheshty1985@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?