Safety and efficacy of venous Paracetamol with venous Ibubrofen in treatment of Patent ductus arteriosus (PDA) among premature Neonates Hospitalized in NICU, Zanjan Ayatollah Musavi Hospital in 2016- 2017
All premature infants having age of 34 weeks or less with diagnosis PDA hospitalized in NICU of Ayatollah Musavi ,Zanjan and having modrate to sever PDA in two or three days after birth diagnosed through echocardiography together with hemodynamic disorder have been included in the current research.
If suspected to have PDA , patientshave been done echocardiography and graded in terms of PDA.
30 infants will be included in the reserch.Half of the patientswill radomly receive Acetaminophen injection interavenous with dose of 15 mg/kg/QID till three days.The other half will recive Ibuprofen injetion with dose of 10mg/kg/daily in the first day and 5 mg/kg/daily in the second and third day.
Before stating reserch ,patient should pass Cr and BUN tests and platlet counting should not have symptoms of bleeding or Thrombocytopenia.Three days after Acetaminophen injection ,echocardiography should be repeted for the patients.In the case of not healing , they will receive Ibuprofen with dose of 10 mg/kg/daily in first day and 5 mg/kg/daily in the following second and third day.Patients will be examined when in hospitalas well as when discharged.According to the finings ,the safety and effectivness of Acetaminophen will be assesed in the form of semi-experimental pilot study.
Strengths of the current study are as follows:
1. The effectivness of Acetaminophen injection has not been studied compared to Ibuprofen in PDA treatment in Iran so far.
2. It seems that Acetaminophen does not have dangerous side effects of Ibuprofen.
3. If the effectivness of the Acetaminophen is proved ,it is cheaper and more available.
General information
Acronym
PDA (Patent ductus arteriosus)
IRCT registration information
IRCT registration number:IRCT2016081729404N1
Registration date:2017-05-09, 1396/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-09, 1396/02/19
Registrant information
Name
Nahid Jafari
Name of organization / entity
zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1255
Email address
nahidjafari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2017-03-16, 1395/12/26
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of venous Paracetamol with venous Ibubrofen in treatment of Patent ductus arteriosus (PDA) among premature Neonates Hospitalized in NICU, Zanjan Ayatollah Musavi Hospital in 2016- 2017
Public title
Safety and efficacy of venous Paracetamol with venous Ibubrofen in treatment of Patent ductus arteriosus (PDA) among premature Neonates Hospitalized in NICU, Zanjan Ayatollah Musavi Hospital in 2016- 2017
Purpose
Treatment
Inclusion/Exclusion criteria
Neonate with 34 week age and less with PDA diagonsis by echocardiography.
Age
From 1 day old to 3 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
4513956183
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.ZUMS.REC.1395.312
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus (PDA)
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
PDA size
Timepoint
PDA size befor and after treatment messured with echocardiography by pediatric cardiologist.
Method of measurement
According to the disease severity and echocardiography results,Patient's PDA will be examined before and after treatment by pediatric cardiologis.
Secondary outcomes
empty
Intervention groups
1
Description
15 infants receive Ibuprofen whit dose of 10 mg/kg/stat in the first day and 5 mg/kg/stat in the following second and third days.
Category
Treatment - Drugs
2
Description
15 infants recieve Acetaminophen IV 15 mg/kg/ every six hours for three days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU, Musavi hospital
Full name of responsible person
Dr. Abolfazl Ebadi
Street address
Musavi hospital , Gavazang
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shogli
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Grant name
بودجه معاونت تحقیقات و فن آوری دانشگاه
Grant code / Reference number
A - 11 - 1091 - 1
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Ebadi
Position
MD/ pediatric resident
Other areas of specialty/work
Street address
Musavi hospital , Gavazang road
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
a.ebadi2016@gmail.com
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Nahid Jafari
Position
Neonatalogist
Other areas of specialty/work
Street address
Musavi hospital , Gavazang
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
nahidjafari@zums.ac.ir
Web page address
www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Ebadi
Position
MD/ pediatric resident
Other areas of specialty/work
Street address
Musavi hospital , Gavazang road
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
a.ebadi2016@gmail.com
Web page address
www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)