Comparison of the therapeutic and Safety effect of oral and rectal acetaminophen for treatment and safety on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old.
Comparison of the therapeutic and Safety effect of oral and rectal acetaminophen for treatment and safety on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old.
Design
This study is a one-blinded clinical trial. The study population will be included all preterm neonates admitted to Mohammad Kermanshahi and Imam Reza Hospital of Kermanshah city.40 eligible preterm neonates will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study that will be conducted in Mohammad Kermanshahi and Imam Reza Hospital of Kermanshah city is one-blinded one. In this way that the researcher will be kept blind to the study groups, the dosage of the drug and the manufacturer of the medicine
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preterm neonates under 35 weeks and 6 days gestational old; Age after birth be over 72 hours and less than 14 days; Neonates with hemodynamic disorders caused by PDA
Exclusion criteria: Respiratory rate more than 80 per minute; Signs of renal failure and oliguria; Creatinine clearance less than 10%
Intervention groups
In the first intervention group, the treatment will begin with the administration of oral acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams.
In the second intervention group, the treatment will begin with the administration of rectal acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams.
Main outcome variables
closure of ductus arteriosus in preterm neonates
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N118
Registration date:2019-04-11, 1398/01/22
Registration timing:registered_while_recruiting
Last update:2019-04-11, 1398/01/22
Update count:0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-12-16, 1398/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic and Safety effect of oral and rectal acetaminophen for treatment and safety on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old.
Public title
Comparison of the effect of oral and rectal acetaminophen on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonates under 35 weeks and 6 days gestational old.
Age after birth be over 72 hours and less than 14 days
Neonates with hemodynamic disorders caused by PDA
Exclusion criteria:
Respiratory rate more than 80 per minute
Signs of renal failure and oliguria
Creatinine clearance less than 10%
Age
From 3 days old to 14 days old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, Clinical care will be kept blind to study groups, the dosage of the drug and manufacturer of the drug. In this way,the clinicians are unaware of participants coding and the dose of the drug that groups will receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
ir.kums.rec.1397.1035
Health conditions studied
1
Description of health condition studied
preterm neonates
ICD-10 code
P07.3
ICD-10 code description
Other preterm neonates
Primary outcomes
1
Description
the closure of ductus arteriosus
Timepoint
The beginning and end of the study
Method of measurement
With echocardiography device
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, the treatment will begin with the administration of oral acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams.
Category
Treatment - Drugs
2
Description
In the second intervention group, the treatment will begin with the administration of rectal acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
hashem Gholami
Street address
Crossroads of Shirkhorshid
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
gholami3280@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hashem Gholami
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Crossroads of Shirkhorshid
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8204
Email
gholami3280@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mazyar Vakili Amini
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Crossroads of Shirkhorshid
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8204
Email
mzvakilia@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hashem Gholami
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Crossroads of Shirkhorshid
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8204
Email
gholami3280@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail