Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates admitted in neonatal intensive care unit of Akbar Abadi Hospital
Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates
Design
A simple randomization (according to table of random number), with a 2 parallel group, N=100 (each group n=50), Not blinded, Phase 3
Settings and conduct
This interventional study will conducted from May 2019 to July 2019. 100 preterm neonate with diagnosis of PDA admitted in NICU of Akbar Abadi Hospital Tehran were selected. Neonates are randomly assigned to two groups. In the first intervention group, oral Acetaminophen is given every 6 hours at a dose of 15 mg / kg for 3 days. In the second intervention group, IV Acetaminophen injected every 6 hours at a dose of 15 mg / kg for 3 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Premature neonate with diagnosis of PDA by pediatric cardiologist
En Written parental consent is obtained
Gestational age 26 to 37 weeks
Exclusion criteria:
No Parental consent.
Any congenital heart disease that requires PDA to maintain blood flow ( Based on patient records).
Life threatening infections .( Based on patient records).
Liver Diseases
Intervention groups
50 neonates in the first intervention group and 50 neonates in the second intervention group. In the first intervention group, oral Acetaminophen is given every 6 hours at a dose of 15 mg / kg for 3 days. In the second intervention group, IV Acetaminophen injected every 6 hours at a dose of 15 mg / kg for 3 days.
Main outcome variables
The closure of the ductus arteriosus (complete, incomplete, unchanged)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190505043478N1
Registration date:2019-05-10, 1398/02/20
Registration timing:registered_while_recruiting
Last update:2019-05-10, 1398/02/20
Update count:0
Registration date
2019-05-10, 1398/02/20
Registrant information
Name
Shadi Adib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
adib.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates admitted in neonatal intensive care unit of Akbar Abadi Hospital
Public title
Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written parental consent is obtained
Gestational age 26 to 37 weeks
Diagnosis of ductus arteriosus based on echocardiographic evidence at 24 to 72 hours after birth
Exclusion criteria:
No Parental consent
Any congenital heart disease with the need to PDA to keep blood flow constant ( Based on patient records).
Life threatening infections .( Based on patient records)
Liver Disease
Age
From 1 day old to 20 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
100 premature neonate assigned with simple randomization, according to table of random number and individual randomization unit. 50 neonates in the first intervention group and 50 neonates in the second intervention group were selected. In this study, do not allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.IUMS.FMD.REC.1398.026
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus (PDA)
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
PDA size
Timepoint
The neonates receives echocardiography before and after treatment.
Method of measurement
Patient PDA evaluated before and after treatment, based on severity of the disease, and findings of the echocardiography by pediatiric's cardiologist .
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received oral Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days.
Category
Treatment - Drugs
2
Description
Intervention group2: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received IV Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Shadi Adib
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
shadiadib95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakoti
Street address
Shahid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
malakouti.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shadi Adib
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
shadiadib95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shadi Adib
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
shadiadib95@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Semira Mehralizadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
mehralizadehmd@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available