For 150 Very Low Birth Weight ( VLBW) infants who are inborn we will send: Blood culture( B/C) with Bacteck method , CBC diff and CRP at the admission . According to the current protocol of hospital empirical Antibiotics will be started too. After 3-5 days with receiving the B/C results ,a CRP will be sent .After receiving the consent of the parents the patients will be divided in two groups. Control group will continued the empirical Antibiotics until the patients have Iv access, in case group antibiotics will be discontinued if the results of B/C and CRP would be negative and clinical condition would not suggestive of infection. The patients will be followed until discharge or death .Early outcomes consist of: Death, Discharge or transport to other centers , Narcotizing Entrocholits( stage 2 or more) will be compared in two groups. Total days of Antibiotic therapy , duration of hospitalization and bacteriologic data will also be compared..
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210124113N3
Registration date:2014-04-24, 1393/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-24, 1393/02/04
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric Health Research center of Tabriz University of Medical Sceinces
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Adverse early Outcomes of Prolonged Initial Empirical Antibiotic Therapy in VLBW Premature Infants
Public title
Evaluation of Adverse early Outcomes of Prolonged Initial Empirical Antibiotic Therapy in Premature Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inborn preterm infants in Alzahra Teaching hospital of Tabriz
Without congenital Anomaleis
Very Low Birth weight ( VLBW): Birth Weight 1499 and less
Admit in 72 hours of life for respiratory Distress or R/O Sepsis
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics committee of Tabrriz University of Medical Sceinces
Street address
Research and Technology Deprtment of university
City
Tabriz
Postal code
Approval date
2013-10-20, 1392/07/28
Ethics committee reference number
92130
Health conditions studied
1
Description of health condition studied
Very Low Birth Weight infants
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
Primary outcomes
1
Description
Nosocomial Infection
Timepoint
from 72 hours of life until Discharge
Method of measurement
Positive blood culture with clinical symptoms
2
Description
Mortality
Timepoint
From admision time until discharge or death time
Method of measurement
Evaluation ang registration form of hospital
3
Description
Necrotizing Entrocolitis ( stage 2 or more)
Timepoint
after the day 5 until discharge
Method of measurement
gastrointestinal symptoms and radiologic evidence
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
from the admition time until discharge
Method of measurement
Registration Form( Medical records of the patient )
2
Description
Total days of Antibiotic therapy
Timepoint
From the first day of admission until discharge
Method of measurement
Registration form ( Medical records of the patient as days )
3
Description
Chronic Lung Disease
Timepoint
Need of Oxygen or Respiratory support more than 28 days after birth
Method of measurement
Registration form(Medical records of the patient)
4
Description
Intraventricular Hemorrage ( Grade 2 or more )
Timepoint
7-10 days after birth
Method of measurement
Brain Sonography
Intervention groups
1
Description
In Control group after starting the empirical Antibiotics at the time of admission they will be continued until the patients have Iv access
Category
Treatment - Drugs
2
Description
in case group after starting the empirical Antibiotics at the time of admission they will be discontinued after 3-5 days if the results of B/C and CRP would be negative and clinical condition would not suggestive of infection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital of Tabriz
Full name of responsible person
Mohammad Bagher Hosseini MD
Street address
Alzahra Teaching Hospital,Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Health Research center of Tabriz University of Medical Sceinces
Full name of responsible person
Dr.Mohammad Barzegar
Street address
Children Hospital of Tabriz
City
TABRIZ
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Health Research center of Tabriz University of Medical Sceinces
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 Sceinces
Full name of responsible person
Dr. Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Neonatology Department,Alzahra Teaching Hospital,Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1335 0357
Fax
Email
hosseini_mb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sceinces
Full name of responsible person
Dr.Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Neonatology Department , Alzahra Teaching Hospital,Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
hosseini_mb@yahoo.com
hossainm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sceinces
Full name of responsible person
Dr. Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Neonatology Department,Alzahra Teaching Hospital of Tabriz,Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
hosseini_mb@yahoo.comhossainm@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)