Protocol summary

Summary
The purpose of this study is to understand whether antibiotics can cause changes in blood cytokine levels or not.Inclusion criteria: All healthy full-term babies, having healthy mothers and normal Apgar scores, suspected of sepsis and candidates for antibiotic treatment in the NICU of Vali-e Asr Hospital. Exclusion criteria: Infants with positive blood cultures, infants with positive cerebrospinal fluid culture, infants being treated with corticosteroids, infants whose mothers were treated with corticosteroids or magnesium sulphate at least one week prior to delivery, infants whose mothers received antibiotics prior to delivery, cord acidosis and birth asphyxia, infants that are intravenously fed, and infants of ill mothers. This is an observational before and after pilot study that examines forty healthy full-term babies suspected of sepsis and candidates for antibiotic treatment in the NICU of Vali-e Asr Hospital. This examination involves taking 1 cc of blood from the infants prior to administration of antibiotics and 1 cc twelve hours after administration of the antibiotics. Using the ELISA test, IL-8, IL-6, IL-1, and TNF-α serum levels will be examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504289568N13
Registration date: 2015-06-02, 1394/03/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences and Shahed university
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examination of proinflammatory and inflammatory cytokines in full-term neonates suspected of sepsis prior to and 12 hours after antibiotic therapy (pilot study)
Public title
Examination of the Effect of Antibiotics on Inflammatory Factors in Neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All healthy full-term babies, having healthy mothers and normal Apgar scores, suspected of sepsis and candidates for antibiotic treatment in the NICU of Vali-e Asr Hospital. Exclusion criteria: Infants with positive blood cultures, infants with positive cerebrospinal fluid culture, infants being treated with corticosteroids, infants whose mothers were treated with corticosteroids or magnesium sulphate at least one week prior to delivery, infants whose mothers received antibiotics prior to delivery, cord acidosis and birth asphyxia, infants that are intravenously fed, and infants of ill mothers.
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical
City
Tehran
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
93-03-91-26214-145324

Health conditions studied

1

Description of health condition studied
Bacterial sepsis of newborn
ICD-10 code
P36
ICD-10 code description
Bacterial sepsis of newborn

Primary outcomes

1

Description
IL-1β
Timepoint
just before and 12 hrs after intervention
Method of measurement
ELISA,pg/ml

2

Description
IL-6
Timepoint
just before and 12 hrs after intervention
Method of measurement
ELISA,pg/ml

3

Description
IL-8
Timepoint
just before and 12 hrs after intervention
Method of measurement
ELISA,pg/ml

4

Description
TNF-α
Timepoint
just before and 12 hrs after intervention
Method of measurement
ELISA,pg/ml

Secondary outcomes

empty

Intervention groups

1

Description
Antibiotic therapy with ampicilin+amikacin or rarely vancomycin+meropenem
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternal Fetal Neonatal Research Center
Full name of responsible person
Golnaz Rezaeizadeh
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed university
Full name of responsible person
Tooba Ghazanfari
Street address
Medical faculty of Shahed university- Abdollahzadeh St.,Keshavarzblv,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed university
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Karbakhsh
Street address
Ghods St., Keshavarz blv,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
Full name of responsible person
Golnaz Rezaeizadeh
Position
researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
golnaz_rezaei80@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
Full name of responsible person
golnaz rezaeizadeh
Position
researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
golnaz_rezaei80@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
Full name of responsible person
Golnaz rezaeizadeh
Position
researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
Phone
+98 216659131600
Fax
Email
golnaz_rezaei80@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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