Clinical trial of the effect of intravenous acetaminophen in patent ductus arteriosus prophylaxis of preterm infants with gestational age less than 32 weeks
Determination of the effect of intravenous acetaminophen on patent ductus arteriosus prophylaxis of preterm infants with gestational age less than 32 weeks
Design
Clinical trial with control group, with parallel groups, single-blinded, and randomized
Settings and conduct
On the first to third day of birth, the first echocardiography will be performed. Then, between day 3 to 5, the echocardiography will be repeated, and condition
of ductus arteriosus will be recorded.
Participants/Inclusion and exclusion criteria
Preterm infants with gestational age less than 32 weeks who are admitted to the NICU ward of Bouali Hospital of Sari for less than 72 hours
Intervention groups
In the intervention group, intravenous acetaminophen manufactured by Iran Exir Company with a dose of 10 mg/kg is injected each 12 hours for two days and in the control group, normal saline made by Daroopakhsh Company at a dose of 10 mg/kg is injected each 12 hours for two days as a placebo
Main outcome variables
One to three days after the intervention, ALT, AST, BUN, Cr, PT and INR tests will be performed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111011007763N2
Registration date:2018-03-03, 1396/12/12
Registration timing:registered_while_recruiting
Last update:2018-03-03, 1396/12/12
Update count:0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Vajihe Ghaffari
Name of organization / entity
mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
vghaffari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-05-24, 1397/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of intravenous acetaminophen in patent ductus arteriosus prophylaxis of preterm infants with gestational age less than 32 weeks
Public title
Effect of intravenous acetaminophen in prevention of patent dactus arteriosus in preterm infants