Effect of prophylactic oral administration of acetaminophen on patent ductus arteriosus(PDA) closure in preterm neonate admitted in NICU section of Ali ibn Abitaleb Hospital in Zahedan in 2019-2020
Evaluation prophylactic oral acetaminophen administration on patent ductus arteriosus closure in preterm neonates based on gestational age and arterial diameter
Design
All preterm neonates with gestational age less than 32 weeks and weight less than 1500 g born in the NICU ward of Ali Ibn Abi Talib Hospital in Zahedan were randomly divided into the intervention group and received acetaminophen 15 mg / day in the intervention group. Each kilogram of body weight is given then on the fifth day of echocardiography will be performed.
Settings and conduct
The study will be carried out at Ali Ibn Abi Talib Hospital in Zahedan and the pediatric cardiologist who performs echocardiography is not aware of the neonatal segmentation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all preterm infants less than 32 weeks gestation and weight less than 1500 gr.
Exclusion criteria: congenital heart disease; congenital major anomalies; non-steroidal anti-inflammatory drug use during pregnancy; persistent pulmonary hypertension; Apgar score less than 5; vomiting and hematemesis; G6PD deficiency; sepsis; intraventricular hemorrhage; urine output less than 1cc/kg/hr; creatinine greater than 1/8 mg/dl; platelet less than 50,000; necrotizing enterocolitis.
Intervention groups
The infants in the intervention group will be given an oral acetaminophen dose of 15 mg / kg from the first day of birth, then echocardiography will be performed on the fifth day of birth. In control group no intervention is performed.
Main outcome variables
Patent ductus arteriosus closure in preterm infants
General information
Reason for update
Acronym
PDA
IRCT registration information
IRCT registration number:IRCT20200218046538N1
Registration date:2020-03-10, 1398/12/20
Registration timing:registered_while_recruiting
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Somayeh Baghiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4781
Email address
som_baghiei1365@vatanmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic oral administration of acetaminophen on patent ductus arteriosus(PDA) closure in preterm neonate admitted in NICU section of Ali ibn Abitaleb Hospital in Zahedan in 2019-2020
Public title
Effect of acetaminophen in patent ductus arteriosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of preterm neonat
Gestational آگه less than 32 week
Weight less than 1500 gram
Exclusion criteria:
Congenital heart disease
Major congenital anomaly
Use of NSAID in pregnancy with mother
Persistant pulmonary hypertention
APGAR scor less than 5
Vomitting or hematemesis
G6PD deficency
Sepsis
Intra ventricular hemorrage
Urin out put less than 1 cc/kg/hr
Cr more than 1/8 mg/dl
Plt less than 50000
NEC
Age
From 1 day old to 5 days old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible neonates are divided into two groups according to the random number table. Neonates with even numbers will be in the intervention group and neonates with odd numbers will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The cardiologist that performs Echocardiography He Does not know that which neonate Received Acetaminophen
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Sadra street, sadra 22
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817957671
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.ZAUMS.REC.1398.250
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus
ICD-10 code
Q20.8
ICD-10 code description
Other congenital malformations of cardiac chambers and connections
Primary outcomes
1
Description
Percentage of patent ductus arteriosus closure in preterm infants
Timepoint
Percentage of patent ductus arteriosus closure in preterm infants on fifth day of birth
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: premature babies with gestational age less than 32 weeks and weight less than 1500 g inter to study Then, from the first day of birth, oral acetaminophen will be given to the infant at 15 mg / kg every 6 hours, and on the fifth day the echocardiography will be performed.
Category
Treatment - Drugs
2
Description
Control group: no intrvention is performed in this group and echocardiography will also be performed on the fifth day of birth without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital in Zahedan
Full name of responsible person
Somayeh Baghiei
Street address
Persian Gulf Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817957671
Phone
+98 54 3329 5584
Email
Som_baghiei1365@vatanmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshany
Street address
Khalij Fars Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817957671
Phone
+98 54 3337 2116
Email
Som_baghiei1365@vatanmail.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Somayeh Baghiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sadra street, Ziba shahr, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817957671
Phone
+98 51 4261 4781
Email
Som_baghiei1365@vatanmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somayeh Baghiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sadra 22, Sadra street, Ziba shahr, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817957671
Phone
+98 51 4261 4781
Email
Som_baghiei1365@vatanmail.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somayeh Baghiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sadra 22, Sadra street, Ziba shahr, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98179577671
Phone
+98 51 4261 4781
Email
Som_baghiei1365@vatanmail.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information is available by patient code
When the data will become available and for how long
From the next 6 months
To whom data/document is available
All body
Under which criteria data/document could be used
Use data to conduct research that is relevant to the health of the community and individuals
From where data/document is obtainable
If you are approved by the university, you will be given a patient code if approved
What processes are involved for a request to access data/document
If you are approved by the university, you will be given a patient code if approved