Comparison of the effect of oral Acetaminophen with oral Ibuprofen in closure of Patent ductus arteriosus (PDA) in preterm neonate with gestational age less than 32 weeks
Comparison the effect of oral acetaminophen and oral ibuprofen in closing of Patent Ductus Arteriosus (PDA) in preterm neonate with gestational age less than 32 weeks in esfahan
Design
Two parallel randomized clinical trial and randomly divided into two groups of 20 patient and result will analysed double blinded.
Settings and conduct
This study was conducted at NICU of Al-Zahra and Shahid Beheshti hospitals of esfahan city and a neonatal nursing and cardiologist that was in charge of clinical follow-up was not aware of the type of drug used in the course of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: neonates with gestational age less than 32 weeks and a maximum age of 14 days and PDA has been confirmed by echocardiography.
Exclusion criteria: neonates with chromosomal anomalies and congenital heart disease and clinical conditions Ibuprofen is contraindicated to start.
Intervention groups
In the first group, oral Acetaminophen is given at a dose of 15 mg / kg every 6 hours for 48 hours, given through the NG tube or through the dropper by a trained nurse. In the second group, oral Ibuprofen is given as 10 mg / kg on the first day and then 5 mg / kg at 24 and 48 hours, followed by a dropper or NG tube.
Main outcome variables
In this study, the effect of ََAcetaminophen on Patent ductus arteriosus, the duration of hospitalization and the complications of its use are investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170801035441N1
Registration date:2018-07-09, 1397/04/18
Registration timing:registered_while_recruiting
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 5881
Email address
m.ghaderian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral Acetaminophen with oral Ibuprofen in closure of Patent ductus arteriosus (PDA) in preterm neonate with gestational age less than 32 weeks
Public title
"Evaluation of the effect of oral acetaminophen on the treatment of neonatal PDAs"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All neonate with 32 weeks or less requiring PDA treatment for clinical conditions
PDA is confirmed by echocardiography
Age less than 14 days
Exclusion criteria:
Congenital heart disease
Clinical and laboratory symptoms of sepsis
Chromosomal or congenital abnormalities
The presence of Ibuprofen is contraindicated
Age
From 1 day old to 14 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, neonates in need of treatment will be divided into two groups using random numbers and each group will receive standard treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, nursing staff have no information about type of treatment. Only protocol 1 and 2 were recorded in follow-up treatment, so the next assessment was blinded by cardiology services, and it was only during the analysis of these protocols that the type of treatment was identified.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, hezar Jereyb St.
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
396994
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 closure rate of patent ductus arteriosus (PDA)
Timepoint
Echocardiography at the beginning of the study and then 48-72 hours after treatment
Method of measurement
Confirmed by echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 48 hours, Drop of Acetaminophen made by the kimia gar Pharma Company at a dose of 15 mg / kg every 6 hours, given through the NG tube or through the dropper, by a nurse trained in neonates.
Category
Treatment - Drugs
2
Description
Control group: Oral Ibuprofen 10 mg / kg on day one and then two doses of 5mg / kg at 24 and 48 hours after administration of the dropper or through the NG tube and administered by a trained NICU nurse.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Banazade
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 42 ,Sajadie 2 Alley , Artesh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5321
Email
amir_banazade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Ghaderian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
no 34, Alley 16,Chaharbaghe Paein st
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3335 5881
Fax
Email
m.ghaderian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Banazade
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 42 ,Sajadie 2 Alley , Artesh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5321
Email
amir_banazade@yahoo.com
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
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
Title and more details about the data/document
A portion of the data will be shared after the non-identifiable patients of study that contain the results of the treatment of Acetaminophen and also the demographic information of the patients.
When the data will become available and for how long
Three months after the publication of the results as an article.
To whom data/document is available
The data is available to researcher working in medical sciences.
Under which criteria data/document could be used
researcher who are doing in pediatric cardiology is available.
From where data/document is obtainable
To find out the data of this research, you can email Amir Binazadeh Resident of pediateric by e-mail.
What processes are involved for a request to access data/document
To access the research data after the request is sent, the researcher will be informed by email within 2 weeks for the delivery of the data to the applicant.