The purpose of this randomized study is using once daily dose of Amikacin versus twice dose daily for treatment of early onset neonatal sepsis. Inclusion criteria: Term Infants with the clinical signs of sepsis in premature newborn infants admitted Bou Ali Sina Hospital of Sari treated with Ampicillin plus Amikacin. Exclusion criteria : fetal age more than 42 Weeks and less than 37 weeks; Low birth weight; having congenital heart disease and asphyxia; not treated with Ampicillin and Amikacin at the age of 7 days; renal and hearing congenital disorders; prescription medications that have toxic effect on renal and auditory systems; neonatal meningitis; pathologic icter and TORCH Infections. Study sample size is 32 patients. Primary outcome: the treatment of SDL peak in therapeutic range and the treatment of through SDL in non-toxic range, 60 minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30mcg/ml. Control group: Treated with Amikacin twice dose of 10 mg/ kg Body weight daily that is within one hour intravenous Infusion. Case groups: treated with amikacin one Dose of 15 mg /kg body weight that is within one hour intravenous infusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112248507N1
Registration date:2012-01-10, 1390/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-10, 1390/10/20
Registrant information
Name
Mohammad Sadegh Rezai
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
rezai@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2013-01-09, 1391/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Once daily dose of Amikacin versus twice daily dose for treatment of early onset neonatal sepsis
Public title
Once daily dose of Amikacin versus twice daily dose for treatment of early onset neonatal sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Term Infants with the clinical signs of sepsis in premature newborn infants admitted Bou Ali Sina Hospital of Sari treated with Ampicillin plus Amikacin.
Exclusion criteria : fetal age more than 42 Weeks and less than 37 weeks; Low birth weight; having congenital heart disease and asphyxia; not treated with Ampicillin and Amikacin at the age of 7 days; renal and hearing congenital disorders; prescription medications that have toxic effect on renal and auditory systems; neonatal meningitis; pathologic icter and TORCH Infections.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
NO.2 Building of University,Moallem Square
City
Sari
Postal code
Approval date
2011-01-19, 1389/10/29
Ethics committee reference number
147-89
Health conditions studied
1
Description of health condition studied
Neonatal sepsis
ICD-10 code
P36
ICD-10 code description
P36.8
Primary outcomes
1
Description
The treatment of SDL peak in therapeutic range
Timepoint
Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30
Method of measurement
Serum samples
2
Description
The treatment of through SDL in non-toxic range
Timepoint
Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30
Method of measurement
Serum samples
Secondary outcomes
1
Description
Potential renal side effects
Timepoint
Before the next dose
Method of measurement
Serum samples
2
Description
Potential hearing side effects
Timepoint
Before the Next Dose
Method of measurement
Auditory brainstem response and audiometry
Intervention groups
1
Description
Control group: treated with Amikacin twice dose of 10 mg/ kg body weight daily that is within one hour intravenous infusion.
Category
Treatment - Drugs
2
Description
Case group: treated with amikacin one dose of 15 mg /kg body weight that is within one hour intravenous infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Hospital of Sari
Full name of responsible person
Dr Mohammadsadegh Rezai
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
NO.2 Building of University,Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammadsadegh Rezai
Position
Associate Professor
Other areas of specialty/work
Street address
Boali Hospital,Pasdaran Blv
City
Sari
Postal code
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
rezai@mazums.ac.irdrmsrezaii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammadsadegh Rezai
Position
Associate Professor
Other areas of specialty/work
Street address
Boali Hospital,Pasdaran Blv.
City
Sari
Postal code
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
rezai@mazums.ac.irdrmsrezaii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammadsadegh Rezai
Position
Associate Professor
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
drmsrezaii@yahoo.comrezai@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)