Studying the efficacy of synchronous consumption of Acetaminophen and Ibuprofen for closure of patent ductus arteriosus (PDA ) in preterm neonates admitted in neonatal intensive care unit
Determining the effect of simultaneous use of acetaminophen and ibuprofen to open the arterial duct in preterm infants admitted to hospitals affiliated to Shiraz University of Medical Sciences
Design
clinical trial on 210 premature infants with PDA which need to be treated, with a control group, pragmatic, with 3 parallel groups, non blinded and simple Random assignment using a random number table.
Settings and conduct
This study was designed to evaluate the effect of different methods of medical treatment of premature infants admitted to the intensive care unit in Nemazee, Hafez and Hazrat Zeinab hospitals in Shiraz. for this purpose 210 premature infant were enrolled in 3 groups of 70.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- premature infants less than 37 weeks
2- premature infants with patent ductus arteriosus who require treatment
exclusion criteria:
1 - NPO
2-massive bleeding from ETT or GI bleeding
3. Platelet count less than 50/000 per milimeter cubic meter
4. Urine output less than 1mililitr per kilogram per hour
5. Serum creatinine greater than 1.5miligram per decilitre
6. Intra-ventricular hemorrhage grade 3 and 4
7. Increase more than 2 times the hepatic enzymes (NL ALT: 6-50 and NL AST: 35-140) (10)
8-Major Congenital Anomalies
9-Congenital Heart Disease
10-Sepsis
11-Persistent Fetal Circulation
Intervention groups
The first group consists of 70 neonate treated with oral ibuprofen in 3 daily doses of 10, 5 and 5 mg per kg body weight per day. The second group consists of 70 premature infants who received an intravenus injection of 15 mg acetaminophen per kilogram of body weight every 6 hours for 3 days. The third group consists of 70 premature newborns who simultaneously receive oral ibuprofen and injectable acetaminophen at the same dose and duration as the other two groups.
Main outcome variables
closing or remaining PDA
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171116037503N2
Registration date:2018-10-30, 1397/08/08
Registration timing:retrospective
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4297
Email address
oboodir@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the efficacy of synchronous consumption of Acetaminophen and Ibuprofen for closure of patent ductus arteriosus (PDA ) in preterm neonates admitted in neonatal intensive care unit
Public title
the effect of Acetaminophen and Ibuprofen for closure of patent ductus arteriosus (PDA )
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
premature infants less than 37 weeks of gestational age
premature infants who require treatment for patent ductus arteriosus
Exclusion criteria:
1 . Prohibition of oral feeding
2.massive bleeding from ETT or GI bleeding
3. Platelet count less than 50/000 per mili cubic meter
4. Urine output less than 1mililitr per kilogram per hour
5. Serum creatinine greater than 1.5miligram per decilitre
6. Intra-ventricular hemorrhage grade 3 and 4
7. Increase more than 2 times the hepatic enzymes (NL ALT: 6-50 and NL AST: 35-140)
8-Major Congenital Anomalies
9-Congenital Heart Disease
10-Sepsis
11-Persistent Fetal Circulation
Age
From 3 days old to 30 days old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
210
Actual sample size reached:
149
Randomization (investigator's opinion)
Randomized
Randomization description
These infants are divided into three groups based on the pattern determined by the simple randomization method and random number table
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 Shiraz University of Medical Sciences
Street address
Zand street, Nemazee hospital
City
ُُُShiraz
Province
Fars
Postal code
7193711351
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.72
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
Closing patent ductus arteriosus
Timepoint
before intervention and on day four after end of treatment
Method of measurement
Ecocardiography
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group consists of 70 premature neonate who received an intravenous injection of 15 mg acetaminophen per kg of body weight every 6 hours for three days.
Category
Treatment - Drugs
2
Description
The second intervention group consists of 70 premature newborns who simultaneously received oral ibuprofen on the first, second and third days, respectively, 10mg ,5mg and 5 mg per kg body weight per day and intravenous injection of 15 mg acetaminophen per kg of body weight every 6 hours for three days.
Category
Treatment - Drugs
3
Description
Includes 70 premature infants treated with oral ibuprofen for three consecutive days with doses of 10 mg, 5 mg and 5 mg per kg body weight per day, respectively.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Roya Oboodi
Street address
Zand street, Nemazee Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
oboodir@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand street, Shiraz Medical University Of Science
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Roya Oboodi
Position
Associate professor of Neonatology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zans street, Nemazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
oboodir@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadije sadat Najib
Position
Assistant Professor of Neonates
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Zand street, Nemazee Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
nzahrasan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roya Oboodi
Position
Assistant Professor of Neonates
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zand street, Nemazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
oboodir@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants data file: information and research data
Ethic form: complete the ethic form by parents
When the data will become available and for how long
The start of the access period 6 month after the registration of the results.
To whom data/document is available
participants data file: researchers and patient
ethic form: patients
Under which criteria data/document could be used
awareness of the study results
From where data/document is obtainable
pediatric ward Shiraz university of medical science
What processes are involved for a request to access data/document
with the letter of introduction from the university 's vice chancellor to the children's department