Efficacy of Acetaminophen versus Ibuprophen in treatment of patent dactus arteriosus (PDA) in neonates
Design
This double blind randomized clinical trial is being conducted in a health center on 60 infants. The specialist and researcher will be blinded throughout the trial. Infants with hemodinamically significant PDA are randomly assigned to either intravenous acetaminophen or oral ibuprofen groups.
Settings and conduct
This double-blind study on the closure of PDA is conducted in the neonatal intensive care unit of Kashan Shahid Beheshti Hospital. The randomization was individual rather than cluster and individuals were assigned to groups based on random numbers generated by computer. In order to guarantee secure allocation concealment, a trained nurse will assign the neonates to different groups in a simple randomization process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All neonates with post natal age more than 3days with hemodynamically significant PDA; Acceptance of inform consent by parents. Exclusion criteria: All congenital heart diseases other than PDA; Contraindication of using ibuprofen or acetaminophen; Persistence fetal circulation (PFC)
Intervention groups
In group A, intravenous Acetaminophen 15mg per kilogram per dose will be used every 6 hour for 3 days. In group B, oral Ibuprofen 10mg per kilogram per dose will be used on the first day and 5mg per kilogram per dose on 2nd and 3rd days. Finally the efficacy of Acetaminophen will be compared against Ibuprofen.
Main outcome variables
Closure of patent dactus arteriosus in neonates.
General information
Reason for update
Acronym
_
IRCT registration information
IRCT registration number:IRCT20170910036112N2
Registration date:2018-03-04, 1396/12/13
Registration timing:registered_while_recruiting
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
sima safaei
Name of organization / entity
kashan university
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 3673
Email address
safaei-s@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Science
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Paracetamol versus Ibuprofen for the treatment of patent ductus arteriosus in neonates
Public title
Efficacy of Paracetamol in treatment of patent dactus arteriosus in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All neonates with post natal age more than 3 days with hemodynamically significant PDA;
Acceptance of inform consent by parents.
Exclusion criteria:
All congenital heart diseases other than PDA
Contraindication of using ibuprofen or acetaminophen
Persistence fetal circulation (PFC)
Age
From 3 days old to 7 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization will be used and the allocation schedule will be planned using a computerized randomization. Infants with patent dactus arteriosus will be randomly assigned to either intravenous acetaminophen or oral ibuprofen. For blinding, a trained nurse with no clinical involvement in the trial, will assign the infants to the groups according to the random allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, neonates with symptoms of patent ductus arteriosus (PDA) undergo echocardiagraphy by a cardiologist who has no information on neonates’ individual characteristics. Those neonates who meet the PDA diagnosis criteria and need treatment are assigned to different drug groups are unknown to the cardiologist.
The diagnosed neonates are categorized to groups A and B according to the specific defined plans and receive treatment. The researcher is not aware of the type of treatment. Finally, echocardiography will be repeated for diagnosed neonates for the second time while the cardiologist is not still aware of the type of the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Scienses, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.KAUMS.REC.1395.164
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus in neonate
ICD-10 code
Q25.0
ICD-10 code description
Patent Ductus Arteriosus
Primary outcomes
1
Description
Closure of PDA in neonate
Timepoint
72 hours after birth and after 3 days of therapy initiation (therapy completion)
Method of measurement
Echocardiography
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Intervention group 2: Oral Ibuprofen 10mg/kg/dose for first day and 5mg/kg/dose for second and third day
Category
Treatment - Drugs
2
Description
Intervention group 1: Intra venous Paracetamol 15mg/kg/dose every 6hours for 3 days