Determining and comparing the effect of injectable Acetaminophen in closure of Patent Ductus Arteriosus (PDA) in full term infants admitted.
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase 3 on 80 patients. Simple randomization was used for randomization.
Settings and conduct
The study was conducted as a randomized, single-blind clinical trial on term infants hospitalized in the special care department of Afzalipur Hospital, Kerman. PDA diagnosis was confirmed by echocardiography on the third day after birth and according to symptoms. Infants were selected by convenient method and were placed in two intervention and control groups by a simple random method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All term babies 37 weeks and more hospitalized due to patent ductus arteriosus, who were at least 3 days old and at most 28 days old;
Exclusion Criteria: Congenital heart defects, multiple congenital anomalies, asphyxia, life-threatening disease, Lack of parental consent.
Intervention groups
Intervention group: The intervention included the use of injectable acetaminophen manufactured by Amin Pharmaceutical Company with a dose of 20 mg based on weight in the first hour and 10 mg based on weight every six hours for three days after the initial dose. Control group : Term infants with patent ductus arteriosus receiving normal saline with the same volume as the drug
Main outcome variables
Closure of ductus arteriosus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057459N1
Registration date:2023-06-24, 1402/04/03
Registration timing:retrospective
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Marjan Nikvarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3271 0683
Email address
nikvarzmarjan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2022-03-19, 1400/12/28
Trial completion date
2022-03-19, 1400/12/28
Scientific title
A comparative study of the effectiveness of injectable Acetaminophen in closing Patent Ductus Arteriosus (PDA) in Term and Preterm Neonates.
Public title
Investigating the effect of injectable Acetaminophen in the treatment of Patent Ductus Arteriosus (PDA).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hospitalized neonates with Patent Ductus Arteriosus(PDA)
All term neonates with a gestational age of 37 weeks and more
The minimum age is 3 days and the maximum age is 28 days.
Exclusion criteria:
Congenital Heart Disease
Multiple Congenital Anomalies
Life Threatening Disease
Asphyxia
Lack of parental consent
Age
From 3 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The rand function of Excel software was used for randomization. Based on the random number obtained in the software, the infants are divided into two groups (intervention and control) and this process will continue for each group up to 40 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is informed about the division of the groups, also the parents of the babies have received explanations about the objectives and how to conduct the research, but parents and babies do not know about the division of the groups (intervention or control). Also, the statistician analyzing the data does not know which of the groups the data collected during the study belongs to, and the coded data in two groups (A and B) were given to the expert and their analysis was done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Afzalipur Medical Education Center - Kerman University of Medical Sciences
Street address
Afzalipur Hospital, Imam Khomeini Highway, Kerman town
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.KMU.AH.REC.1400.243
Health conditions studied
1
Description of health condition studied
Neonatal Patent Ductus Arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
Closure of patent ductus arteriosus in neonates.
Timepoint
Opening of the ductus arteriosus: before the start of the study and on the third day and the sixth day after receiving injectable acetaminophen
Method of measurement
Eco cardiography
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: included the use of injectable acetaminophen by Amin company with a dose of 20 mg based on weight, in the first hour and 10 mg based on weight, for every six hours, for three days after the initial dose.
Category
Treatment - Drugs
2
Description
Control group: included the use of normal saline injection with a volume equal to the drug in the first hour and every six hours for three days after the initial dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Mohammad Mehdi Bagheri
Street address
Afzalipur Hospital, Imam Khomeini Highway, Kerman town
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
mehdi_b_ped@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
research and technology department, at the beginning of Ibn Sina street, Somaye intersection (Tahmasababad), Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
r_malekpoor@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Bagheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipur Hospital, Imam Khomeini Highway, Kerman town
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
0098343138000
Email
mehdi_b_ped@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Bagheri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipur Hospital, Imam Khomeini Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
medi_b_ped@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Bagheri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipur Hospital, Imam Khomeini Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
mehdi_b_ped@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
Undecided - It is not yet known if there will be 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