The goal of study is to determine the effect of high dose oral ibuprofen in patent with ductus arteriosus (PDA) in term neonate.The study population are neonates with gestational age 37 weeks or more and 3 to 30 days after birth. The inclusion criterion is patent ductus arteriosus, the exclusion criteria include: congenital heart disease (CHD) dependent to PDA, kidney disease, coagulating disorders and inability to oral feeding.
Sample size is 33 neonates. All neonates receive oral ibuprofen (single dose 20 mg/kg in first day, 10 mg/kg in second day and 10 mg/kg in third day). Doppler Echocardiography is done one day before and one day after treatment. All neonates are monitored for the side effects of drug such as , gastrointestinal bleeding, impaired renal function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112220029N1
Registration date:2014-12-22, 1393/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Mehrdad Rezaei
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5479
Email address
m_rezaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose oral ibuprofen in treatment of patent ductus arteriosus in term neonate
Public title
Effect of ibuprofen in treatment of congenital heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age 37 weeks or more, age of after birth: 3 to 30 days, patent ductus arteriosus.
exclusion criteria: congenital heart disease dependent to patent ductus arteriosus, unable to feeding, bleeding tendency disorder, oliguria, creatinin more than 1.8 mg/dl.
Age
From 3 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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,Central Building of Shiraz University Of Medical Science
City
Shiraz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
CT-P-91-6370
Health conditions studied
1
Description of health condition studied
Patent ductus arteriousus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriousus
Primary outcomes
1
Description
closure of dutus arteriosus
Timepoint
one day before intervention and one day after end of intervention
Method of measurement
Doppler Echocardiography Vivid 3 ultrasound machine GE vingmed, Horten, Norwey
Secondary outcomes
1
Description
side effects like decrease urine output, gastrointestinal bleeding and discomfort, impaired renal function
Timepoint
one day before intervention, second day of intervention, one day after intervention
Method of measurement
clinical evaluation and check CBC, Creatinin , platelet, urine output
Intervention groups
1
Description
Administer oral ibuprofen(suspension 100 mg/5 ml from Hakim drug company) as 20 mg/kg in first day,10 mg/kg in second day and 10 mg/kg in third day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr. Mehrdad Rezaei
Street address
Zand street, Namazi Hospital, Neonatal Intensive Care Unit
City
Shiraz
2
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr. Mehrdad Rezaei
Street address
Chamran street, Hafez Hospital, Neonatal Intensive Care Unit
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research Of Shiraz University Of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Zand Street, Central building of Shiraz University Of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research Of Shiraz 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
Shiraz University Of Medical Science
Full name of responsible person
Dr.Mehrdad Rezaei
Position
Neonatology subspecialist
Other areas of specialty/work
Street address
Zand street, Namazi Hospital, Pediatric department office, Shiraz Neonatology Research Center
City
Shiraz
Postal code
7193711354
Phone
+98 71 3647 9248
Fax
Email
m_rezaei@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr. Mehrdad Rezaei
Position
Neonatology subspecialist
Other areas of specialty/work
Street address
Zand street, Namazi hospital, Pediatric department office, Shiraz Neonatology Research Center
City
Shiraz
Postal code
7193711354
Phone
+98 71 3647 9248
Fax
Email
m_rezaei@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr.Mehrdad Rezaei
Position
Neonatology subspecialist
Other areas of specialty/work
Street address
Zand street, Namazi hospital, Pediatric department office, Shiraz Neonatology Research Center
City
Shiraz
Postal code
7193711354
Phone
+98 71 3647 9248
Fax
Email
m_rezaei@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)