Patent ductus arteriosus is a great way communication normally open to the fetus and Main artery that connects the pulmonary trunk to the descending aorta and the main part of the right ventricle into the lungs causes the blood to be transported to the systemic circulation. Patent ductus arteriosus remains open lead to symptoms such as distance increases systolic and diastolic pressure, pulse, filling or bonding, increased need for oxygen, pulmonary edema, tachycardia, Kvrdyvm blades are activated and eventually right heart failure. The aim of this study was to evaluate the efficacy of oral ibuprofen to close patent ductus arteriosus in neonates is. The purpose of this clinical trial, infants with patent ductus arteriosus and Taleghani Hospital of Kabir the total of 60 neonates with patent ductus arteriosus according to criteria (term neonates born ≥ 3 days of age, proof of patent ductus arteriosus by echocardiography) and randomly assigned to two groups (mg/kg20 as an initial dose of oral ibuprofen and mg/kg10 every 24 hours for two days) and control (mg/kg10 as an initial dose of oral ibuprofen and mg/kg5 every 24 hours for two days) groups. 24 hours and 2 weeks after the third dose drug echocardiography and the results are recorded. Finally, the results between the two groups were analyzed using SPSS statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102215113N1
Registration date:2013-12-04, 1392/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Manuchehr Soltani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.msoltani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-08-21, 1392/05/30
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral ibuprofen for patent ductus arteriosus closure in infants
Public title
Effect of oral ibuprofen for patent ductus arteriosus closure in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:term infants (gestational age 37-42 weeks); Life Age ≥ 3 days of patent ductus arteriosus by echocardiography ; Proof of completion of an informed consent form
Exclusion criteria: There is a reluctance to participate in the study ; Contraindications including ibuprofen creatinine> 8/1; platelet count less than 50,000 ;active gastrointestinal hemorrhage or intraventricular hemorrhage (confirmed by ultrasound); Antrkvlyt necrosis and sepsis; patent ductus arteriosus associated with other disorders; such as TORCH (intrauterine infection).
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University Medical Sciences
Street address
Hoda Elm Street, Amirkabir, Arak
City
arak
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
92-151-14
Health conditions studied
1
Description of health condition studied
Closure of patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
patent dactus arterioussus
Primary outcomes
1
Description
Gastrointestinal bleeding
Timepoint
Before treatment - after each drug administration.
Method of measurement
Blood
2
Description
Platelet count
Timepoint
Before treatment - after each drug administration.
Method of measurement
Blood
Secondary outcomes
1
Description
Serum creatinine
Timepoint
Before treatment - after each drug administration.
Method of measurement
blood
Intervention groups
1
Description
Case Groups: mg/kg20 oral ibuprofen as an initial dose every 24 hours for two days will receive mg/kg10.
Category
Treatment - Drugs
2
Description
Control group: mg/kg10 oral ibuprofen as an initial dose every 24 hours for two days and mg/kg5 will receive.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital Arak
Full name of responsible person
Dr. Soltani Manuchehr
Street address
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.davood hekmatpoo
Street address
Hoda Elm Street, Hospital Amirkabir, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Parstoo Molaei Tavana
Position
Resident of General Pediatric Diseases
Other areas of specialty/work
Street address
Hoda Elm Street, Hospital Amirkabir, Arak
City
Arak
Postal code
Phone
+86 33134716
Fax
Email
dr_p1984@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Matuchehr Soltani
Position
Specialty of Pediatric Cardiology
Other areas of specialty/work
Street address
Arak, Hoda Elm Street, Amir Kabir Hospital
City
Arak
Postal code
Phone
+86 33134716
Fax
Email
m-soltani.md@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Parasto Molaei Tavana
Position
Resident of General Pediatric Diseases
Other areas of specialty/work
Street address
Hoda Elm Street,Hospital Amirkabir, Arak
City
Arak
Postal code
Phone
+86 33134716
Fax
Email
dr_p1984@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)