Protocol summary

Summary
In a randomized clinical trial , admitted premature neonates to NICU of Shahid Sadoughi Hospital , Yazd, Iran will be enrolled and randomly assigned to two groups. Laboratory tests including CBC, CRP, blood culture and urine culture will be performed for all participants at baseline and at the end of fourteenth day of the study. Both groups will be treated with the same antibiotics. In group I, subcutaneous GCSF in dosage of 10 μg / kg / day will be given for 5 consecutive days and the other group will receive normal saline subcutaneously. The neonates will be followed up for 14 days and respiratory status (oxygen dependency or need to mechanical ventilation), amount of tolerated feeding , occurrence of abdominal distension, side effects of injection, fever occurrence and its duration, thrombocytopenia, weight gain, confirmed documented sepsis by cultures and mortality will be evaluated in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303252639N11
Registration date: 2013-04-04, 1392/01/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-04, 1392/01/15
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of G-CSF efficacy in treatment of premature neonates with neutropenia and clinical sepsis
Public title
G-CSF in treatment of premature neonates with neutropenia and clinical sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Gestational age of 30-37 weeks 2- Age of less than 10 days 3- Total neutrophil count ≤ 5000 in μL 4- The neonate has sepsis based on clinical criteria Exclusion criteria: 1- Severe asphyxia 2- Life threatening congenital malformations 3- Total leukocytes count ≥ 20.000 in μL 4- Intraventricular hemorrhage grade 3 or 4 5- Thrombocytopenia ( platelets less than 150000 in μL) 6- Anemia ( Hemoglobin≤10g/dL) 7- Metabolic acidosis (PH ≤ 7.2)
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
ُُShahid Bahonar square
City
Yazd
Postal code
Approval date
2012-09-05, 1391/06/15
Ethics committee reference number
119132

Health conditions studied

1

Description of health condition studied
neonatal sepsis
ICD-10 code
B99
ICD-10 code description
Other infectious diseases

Primary outcomes

1

Description
oxygen dependency
Timepoint
continuously
Method of measurement
pulse oximetery

2

Description
need to mechanical ventilation
Timepoint
continuously
Method of measurement
pulse oximetery

3

Description
amount of tolerated feeding
Timepoint
daily
Method of measurement
clinical exam

4

Description
mortality
Timepoint
continuously
Method of measurement
clinical exam

5

Description
side effects of injection
Timepoint
continuously
Method of measurement
clinical exam

Secondary outcomes

1

Description
confirmed documented sepsis by cultures
Timepoint
at the end of fourteenth day of the study
Method of measurement
based on results of cultures

2

Description
occurrence of abdominal distension
Timepoint
continuously
Method of measurement
clinical examination

3

Description
fever occurrence and its duration
Timepoint
continuously
Method of measurement
clinical examination

4

Description
thrombocytopenia
Timepoint
daily
Method of measurement
laboratory

Intervention groups

1

Description
subcutaneous GCSF in dosage of 10 μg / kg / day for 5 consecutive days
Category
Treatment - Drugs

2

Description
normal saline subcutaneously
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Mostafa Froomandi
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
Bahonar Square, Central Building of University
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .
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
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Lila Borjian
Position
Assistant professor, neonatologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi Blvd, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
leila1890@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Mostafa Froomandi
Position
Pediatric resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi Blvd, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
dr.froomandi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Mostafa Froomandi
Position
Pediatric resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital , Ave - Sina Blvd, Shahid Ghandi Blvd, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
dr.froomandi@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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