This is a comparative prospective study on two different doses of captopril on congestive heart failure in newborn infants .This study is going to be done on 20 newborn infants in Nemazee hospital suffering congestive heart failure due to left to right shunt fallowing congenital heart disease. Doppler Echocardiography will be done on day one and three and clinical evaluation done using Rose Score after the third day of treatment with Digoxin and Lasix. The patients are blindly divided in two groups for two different doses of captopril, 0.03mg/kg and 0.3mg/kg respectively. After 7 days the two groups will be evaluated clinically and with Doppler echo cardiographically. In the second and third evaluation the serum level of rennin and Aldostrone will be checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072910441N1
Registration date:2013-01-11, 1391/10/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-11, 1391/10/22
Registrant information
Name
Narjes Pishva
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5481
Email address
pishvan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz university of medical sciences; Neonatology Research Center
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of high and low doses of captopril in congestive heart failure (CHF) with left to right shunt
Public title
Comparison of high and low doses of captopril in congestive heart failure (CHF) with left to right shunt
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: congenital heart disease with left to right shunt. Exclusion criteria: Trisomy 21, congenital anomalies including cleft lip and cleft palate esophageal atresia.
Age
From 1 year old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Shiraz university of medical sciences
Street address
Zand street
City
Shiraz
Postal code
71937-11354
Approval date
2011-11-24, 1390/09/03
Ethics committee reference number
ct-90-5808
Health conditions studied
1
Description of health condition studied
congenital heart disease
ICD-10 code
Q20.9
ICD-10 code description
Congenital malformation of cardiac chambers and connections, unspecified
Primary outcomes
1
Description
The effect of captopril
Timepoint
The first, third and 7th day of treatment
Method of measurement
Rose score, Echocardiography
Secondary outcomes
1
Description
Serum Renin and Aldostron
Timepoint
The 7th day
Method of measurement
Renin and Aldostron level and Echocardiography
Intervention groups
1
Description
captopril, 0.03mg/kg for 7 days
Category
Treatment - Drugs
2
Description
Captopril, 0.3mg/kg for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Nemazee Hospital
Full name of responsible person
Dr. Narjes Pishva
Street address
Nemazee Hospital, Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Hatam
Street address
building of university of medical science 7th floor, dean of research, Zand street
City
Shiraz
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
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 sciences
Full name of responsible person
Dr. Saeed Alinejad
Position
Fellowship of neonatalogy
Other areas of specialty/work
Street address
Hospital Nemazee, Zand street
City
Shiraz
Postal code
7193711354
Phone
+98 71 1612 5481
Fax
+98 71 1647 4298
Email
salinejad@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Hamid Amoozgar; Narjes Pishva
Position
Associate professor of pediatric; professor of pediatric
Other areas of specialty/work
Street address
Nemazee Hospital, Zand street
City
Shiraz
Postal code
7193711354
Phone
+98 71 1612 5481
Fax
+98 71 1647 4298
Email
amozgah@sums.ac.ir ; pishvan@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Marzieh Dashtpeyma
Position
researcher
Other areas of specialty/work
Street address
Neonatal research center, Nemazee Hospital , Zand street
City
Shiraz
Postal code
7193711354
Phone
+98 71 1612 5481
Fax
+98 71 1647 4298
Email
marziehdashtpeyma@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)