Protocol summary

Summary
The aim of this study is to compare the renal damage caused by standard and once daily dose of Amikacin in premature infants with suspected sepsis.According to formula, the sample volume will be 40 infants. This study will be carried out in “Shahid Akbar Abadi” Hospital. Inclusion criteria:Preterm infants with normal intrauterine growth and sepsis suspicion at birth Exclusion criteria:Neonate who received incomplete treatment ;Parents dissatisfaction for continuation of treatment;asphyxia; renal anomalies in ultrasound after birth. Preterm neonates with sepsis diagnosis will be divided to two groups (A and B) randomly. One group of neonates will receive standard dose of Amikacin and the other one, single daily dose. All of them will also receive 100 mg / kg / d Ampicillin each 8 or 12- hour. Before initializing the treatment, CBC, diff, blood culture, BUN, creatinine and urinary N-GAL will be checked. To rule out renal anomalies in infants during the first week after birth, ultrasound of the kidneys and urinary tract will be done. CBC, diff, BUN and creatinine will be rechecked on the third and fifth days of the treatment. In both groups, maximum and minimum of Amikacin serum level will be checked. The maximum Amikacin serum level will be reached 30 minutes after injection. With this sample the level of creatinine in the blood will also be checked. To determine the minimum level of Amikacin serum, sampling is done 30 minutes before the first injection of Amikacin on the fifth day. With this sample serum creatinine level is also measured. Urinary NGAL levels will be measured on the seventh day. Sampling will continue to the seventh day of treatment and until the number of children who have urinary N-GAL levels in each group (A and B) reaches 20.To study the adverse effects of Amikacin on kidneys, serum creatinine level and urinary N-GAL will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015103124804N1
Registration date: 2016-02-05, 1394/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Arash Bordbar
Name of organization / entity
Iran universty of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 9030
Email address
bordbar.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adverse kidney effects of standard -daily dosing versus once daily dosing of amikacin among preterm neonates
Public title
Adverse effects of amikacin on preterm infants kidneys
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Appropriate for gestational age preterm infants with early onset sepsis diagnosis Exclusion criteria:neonates with incomplete treatment ; whom their parents do not accept to be included in this trial ; asphyxia; kidney anomalies in ultrasonography
Age
To 7 days 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)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Tehran, Iran
City
Tehran
Postal code
Approval date
2015-09-01, 1394/06/10
Ethics committee reference number
IR.IUMS.REC.1394.9111165005

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
Urinary NGAL rising
Timepoint
at admission before initialling amikacin and at 7th day after completing treatment
Method of measurement
Using Urinary NGAL kit

Secondary outcomes

1

Description
serum cr & BUN rising
Timepoint
at admission and 3th, 5th and 7th day
Method of measurement
by blood sampling

Intervention groups

1

Description
Amikacin administration as once daily dose intravenously for 7 days
Category
Treatment - Drugs

2

Description
Amikacin administration as standard daily dose intravenously for 7 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Dr Arash Bordbar
Street address
Shahid Akbarabadi Hospital, Mowlavi st, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyyed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, 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
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Arash Bordbar
Position
Neonatologist/ Professor Assistant
Other areas of specialty/work
Street address
Shahid Akbarabadi Hospital, Mowlavi st, Tehran,Iran
City
Tehran
Postal code
1168743514
Phone
+98 21 2296 9030
Fax
+98 21 5560 8012
Email
bordbar.a@iums.ac.irdrarashbordbar@gmail.comdrabordbar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Arash Bordbar
Position
Neonatologist/ Professor Assistant
Other areas of specialty/work
Street address
Shahid Akbarabadi Hospital, Mowlavi st, Tehran, Iran
City
Tehran
Postal code
1168743514
Phone
+98 21 2296 9030
Fax
+98 21 5560 8012
Email
bordbar.a@iums.ac.irdrarashbordbar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Arash Bordbar
Position
Neonatologist/ Professor Assistant
Other areas of specialty/work
Street address
Shahid Akbarabadi Hospital, Mowlavi st, Tehran, Iran
City
Tehran
Postal code
1168743514
Phone
+98 21 2296 9030
Fax
+98 21 5560 8012
Email
bordbar.a@iums.ac.irdrarashbordbar@gmail.comdrabordbar@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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