Comparison of the efficacy of parenteral Acetaminophen and oral Ibuprofen on the treatment of patent ductus arteriosus in premature infants with very low weight
Comparison of the effects of injectable acetaminophen and oral ibuprofen in the treatment of patent ductus arteriosus in very low birth weight premature infants
Design
A clinical trial with two intervention groups
Settings and conduct
The study will be conducted in newborns hospitalized in NICU and neonatal ward in Shahid Motahari and Kausar hospitals in Urmia city of iran.
Babies will be divided into two groups using the data randomization table And two different medication will be prescribed for each group and a comparison will be made between the response to the treatment and the side effects of the treatment between these two groups.
Participants/Inclusion and exclusion criteria
Infants with a gestational age of less than 32 weeks and a birth weight of less than 1500 grams
Intervention groups
In this study, we have two groups of neonate with open ductus arteriosus, one group of them will receive injectable acetaminophen at a dose of 15 mg per kilogram of body weight every six hours for three days and for the other group We will give oral ibuprofen at a dose of 10 mg per kilogram of body weight daily for three days
Main outcome variables
The size of the patent ductus arteriosus and its size after the use of the two mentioned treatments, the incidence of complications mentioned in different treatments such as bleeding and increased liver enzymes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230828059282N1
Registration date:2023-10-24, 1402/08/02
Registration timing:registered_while_recruiting
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Shadi Irankhah Shiraz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 229 0322
Email address
shirankhahsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of parenteral Acetaminophen and oral Ibuprofen on the treatment of patent ductus arteriosus in premature infants with very low weight
Public title
Acetaminophen vs Ibuprofen in treatment of patent ductus arteriosus in premature infants with very low weight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Prematurity
Not physiologicaly closed patent ductus arteriosus
Very low weight
Exclusion criteria:
Sepsis
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used, so that at first all the possible states of the combination AABB will be listed, then according to the sample size (40) and the block size equal to 4, 10 blocks will be
randomly selected. will be selected. The selection of randomization will be such that first all possible combinations of 4 will be listed and a code will be assigned for each, and then 10 blocks will be selected and listed in order, and the allocation of people will be based on this list. The codes will be secret and only available to the epidemiological consultant. All steps will be done under the supervision of an epidemiologist and using Random Allocation software, version one.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of urmia university of medical sciences