We study the effect of intra venous immunologlobolin (IVIG) on premature neonates with blood culture proven sepsis. Treatment with single dose 1gr IVIG plus antibiotics in 25 individuals of intervention group and treatment with antibiotics only in 25 individuals of control group will be done. Finally we compare the mortality between case and control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710301378N4
Registration date:2009-03-18, 1387/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-03-18, 1387/12/28
Registrant information
Name
Ahmadshah Farhat
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
farhata@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2002-07-05, 1381/04/14
Expected recruitment end date
2003-07-05, 1382/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous immunoglobulin on reduction of sepsis mortality
Public title
Effect of intravenous immunoglobulin on reduction of sepsis mortality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Preterm infants that have birth weight less than 2500gr with positive blood culture and admitted in NICU of Emamreza hospital.
Exclusion criteria: Congenital anomaly, severe pulmonary problem or ventilation, cardiac disease, nephrologic problem
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Vice chancellor for research of Mashhad University of Medical Sciences
Street address
Ghoreshi bilding - Daneshgah street
City
Mashhad
Postal code
Approval date
2003-10-08, 1382/07/16
Ethics committee reference number
1520-ت
Health conditions studied
1
Description of health condition studied
neonate infection
ICD-10 code
P36.9
ICD-10 code description
Bacterial sepsis of newborn, unspecified
Primary outcomes
1
Description
mortality
Timepoint
the end of study
Method of measurement
mortality rate
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: 1000mg/K IVIG single dose + Routine antibiotic therapy
Category
Treatment - Drugs
2
Description
control group: Routine antibiotic therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Emamreza hospital
Full name of responsible person
ِِDr.Ashraf mohammadzadeh
Street address
NICU- Emamreza hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr jalil tavakol afshari
Street address
Ghoreshi bulding-Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)