Effect of oral acetaminophen on the closure of Patent Ductus Arteriosus in preterm neonates
Design
The aim of this study is to compare the effect of oral acetaminophen and ibuprofen on closure of patent ductus arteriosus (PDA) in premature neonates. This is a randomized; without placebo-controlled; single center study. Premature neonates with 32 weeks or less with PDA will be enrolled in the study. Neonates who have congenital heart disease associated with arterial ducts will be excluded. Ninety premature neonates (32 weeks or less) with PDA at Tabriz Pediatric Children's Hospital, randomly (interlaced) will be divided into two parallel groups of intervention and control.
Settings and conduct
Ninety premature neonates (32 weeks or less) with patent ductus arteriosus at Tabriz Pediatric Children's Hospital, will be divided into two parallel groups. Patient informed consent will be obtained. The intervention group is premature neonates who will receive oral acetaminophen 10 mg/kg every six hours for three days. The control group is premature neonates who will receive oral ibuprofen 10 mg/kg at first day and 5 mg/kg at second and third day.
Participants/Inclusion and exclusion criteria
Inclusion criteria are:
1. neonates 32 weeks or less
2. neonates with Patent Ductus Arteriosus
Exclusion criteria are:
1. Congenital heart disease associated with Patent Ductus Arteriosus
2- neonates with syndromes
3- Increased pulmonary arterial pressure with right to left shunt
4. neonates whom have gastrointestinal intolerance
Intervention groups
Intervention group includes premature neonates who will receive oral acetaminophen 10 mg/kg every 6 hours for three days.
Control group includes premature neonates who will receive oral ibuprofen 10 mg/kg on day 1 and 5 mg/kg on day 2 and day 3.
Main outcome variables
The initial outcome is the closure of Patent Ductus Arteriosus.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171227038102N1
Registration date:2018-07-03, 1397/04/12
Registration timing:retrospective
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Mahmoud Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7310
Email address
dr.samadi.pediatrics@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
2014-06-26, 1393/04/05
Actual recruitment end date
2016-05-01, 1395/02/12
Trial completion date
empty
Scientific title
Investigation effect of oral acetaminophen and ibuprofen on Patent Ductus Arteriosus in preterm neonates
Public title
Investigation effect of oral paracetamol in closing PDA in premature neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
preterm neonate
Patent Ductus Arteriosus
Exclusion criteria:
Congenital heart disease afflicted by PDA
Neonates with syndromes
Increased pulmonary arterial pressure with left to right shunt
Neonates who have digestive intolerance
Age
To 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
interlaced
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients randomly (interlaced) will be divided into two parallel groups of intervention and control and patients will not know about division of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz Children's Hospital, Sheshgelan, Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
9346
Health conditions studied
1
Description of health condition studied
Patent Ductus Arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
Closure of Patent Ductus Arteriosus
Timepoint
At the beginning of the study
Method of measurement
By echocardiography
Secondary outcomes
1
Description
Side effects
Timepoint
The entire study period
Method of measurement
Serial clinical examinations
Intervention groups
1
Description
Intervention group: Premature infants who received oral acetaminophen 10 mg/kg every six hour for three days.
Category
Treatment - Drugs
2
Description
Control group: Premature infants who received oral ibuprofen 10 mg/kg on day 1 and 5 mg/kg on day 2 and day 3.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Mahmoud Samadi
Street address
Sheshgelan, Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Email
dr.samadi.pediatrics@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoudpour
Street address
Vice chancellor for research, Tabriz Medical Unversity, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1385 1117
Fax
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Samadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan, Tabriz, East Azerbaijan, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Email
dr.samadi.pediatrics@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Nabaee
Position
Resident of pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan, Tabriz, East Azerbaijan, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
zahranabaeepediatric@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Nabaee
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan, Tabriz, East Azerbaijan, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
zahranabaeepediatric@gmail.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