Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus admitted to the neonatal intensive care unit of Imam Reza (AS) Hospital in Mashhad
Comparison of the effectiveness of oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus
Design
This study will be performed as a clinical trial design with parallel groups with control group, double-blind, randomized phase 3 on 100 infants; Random number table was used for randomization using www.randomization.com.
Settings and conduct
Seventy premature infants admitted to NICU of Imam Reza Hospital with a gestational age of 37 weeks and less or weighing 2000 g or less with an open arterial canal with clinically significant symptoms and echocardiography will be included in the study. One group received intravenous acetaminophen and the intervention group received oral acetaminophen. Those patients who do not respond to two courses of drug treatment will be candidates for surgical treatment. At the end of treatment, efficacy will be compared based on echocardiographic findings and clinical signs and possible drug side effects, comorbidities, and mortality. This blind two-way study (evaluator and analyst) will be performed
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Premature infants with diagnosis of open arterial duct
2. Parents' consent
3. Gestational age 37 weeks and less
4- weight 2000 grams and less than 2000 gram
Exclusion criteria:
1. congenital heart disease that requires PDA
2. Liver disease
3. Active necrotizing enterocolitis or intestinal perforation
4. Gastrointestinal bleeding
Intervention groups
The control group received standard treatment (intravenous acetaminophen) and the intervention group received paracetamol.
Main outcome variables
The rate of arterial duct closure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140907019076N3
Registration date:2021-09-29, 1400/07/07
Registration timing:retrospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 261 7030
Email address
saeedir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus admitted to the neonatal intensive care unit of Imam Reza (AS) Hospital in Mashhad
Public title
Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm newborns with persistent patent ductus arteriosus by echocardiography pediatric cardiologist
Parents' consent
Gestational age less than 37weeks
Birth weight less than 2000 gr
Exclusion criteria:
Congenital heart disease that requires Patent ductus arteriosus (PDA)
Liver diseases
Active necrotizing enterocolitis or intestinal perforation
Gastrointestinal bleeding
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The study design is done in parallel in which the two groups are compared over time. Method used to generate a random allocation sequence using the name of the software or site used: Table of random numbers using the site www.randomization.com
The type of randomization is simple and the method of concealment is in the form of sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and analyst will be unaware of the case and control groups. Patients will be blinded to the type of intervention and the researcher who must enter the data into the relevant checklist will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhdad University of Medical Sciences
Street address
Central building of Mashhad University of Medical Sciences (Ghorsi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.342
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus neonates
Primary outcomes
1
Description
Persistent patent ductus arteriosus
Timepoint
Echocardiography before treatment and after treatment for 24 hours
Method of measurement
IPX7 echocardiography device with CA1-7AD curve probe is used for echocardiography.
Secondary outcomes
1
Description
Arterial duct closure time
Timepoint
After the end of treatment
Method of measurement
Echocardiography
2
Description
Number of courses of treatment
Timepoint
After diagnosis, it is treated for three days and if necessary, a three-day period is repeated.
Method of measurement
Echocardiography
3
Description
Medication side effects
Timepoint
Throughout the treatment and after the end of treatment
Method of measurement
Clinical signs and lab tests
4
Description
Comorbidities and mortality
Timepoint
During treatment
Method of measurement
Clinical signs and lab tests
Intervention groups
1
Description
Intervention group: 15 mg / kg prakid acetaminophen drop (100 mg/ml) will prescribed every 6 hours for 3 days and 15 mg / kg intravenous acetaminophen every 6 hours for 3 days.
Category
Treatment - Drugs
2
Description
Control group: Caspian Iranian intravenous acetaminophen at a dose of 15 mg / kg every 6 hours for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Atiyeh Eshkil
Street address
Neonatal Intensive care unite, Imam Reza hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
eshkils941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences (Ghorshi), daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Eshkil
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
38521121
Email
eshkils941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Eshkil
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iaran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
38521121
Email
eshkils941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Eshkil
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghoreshi Building of Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
38521121
Fax
Email
eshkils941@mums.ac.ir
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
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data can be accessible through an email to the corresponding author
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institute.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month
What processes are involved for a request to access data/document