We enrolled 70 neonates with gestational age equal or below than 32 w and birth weight 800-1500 g and divided them with rand list software in two groups. In intervention group we used iv indomethacin (35 neonates) then two groups were evaluated with echocardiography in 4th day and transcranial sonosgraphy in 7th day and other complications were compared between two groups.
General information
Acronym
PDA
IRCT registration information
IRCT registration number:IRCT201107117010N1
Registration date:2011-10-17, 1390/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-17, 1390/07/25
Registrant information
Name
Mahmood Samadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2280
Email address
samadima@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences and Health Services
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic intravenous Indomethacin effect in decreasing symptomatic Patent Ductus Arteriosus (PDA) and assisted ventilation
Public title
Closure of venous that remained patent from fetal duration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: birth in Alzehra hospital and gestational age equal or lower than 32 week; birth weight equal or between 800-1500g. Exclusion criteria: congenital anomaly; severe asphyxia; thrombocytopenia(plt<50000); creatinine >1.8mg\dl; bleeding tendency; mother consumption of indomethacine.
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences and Health Services
Street address
Golgasht avenue
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
5\4\2573
Health conditions studied
1
Description of health condition studied
Patent Ductus Arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Persistent ductus arteriosus
Primary outcomes
1
Description
Decreasing symptomatic PDA (severity of PDA)
Timepoint
4 days
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Decreasing assisted ventilation
Timepoint
First 14 days of birth
Method of measurement
Visit
Intervention groups
1
Description
Intervention group: Intravenous (IV) indomethacin at 2-12 first hours with dosage of 0.2mg\kg and then 0.1mg/kg after 24 and 48 hours
Category
Treatment - Drugs
2
Description
Control group: without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzehra hospital
Full name of responsible person
Dr Mahmood Samadi, associated professor
Street address
Alzehra hospital, Artesh avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical sciences, Daneshgah Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences and Health Services
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
Tabriz University of Medical Science, Pediatric Department
Full name of responsible person
Dr Mahmood Samadi
Position
Pediatric Cardiologist, Associated Professor, Head of Pediatric Ward