Effect of intravenous Aminophylline injection on preventing renal dysfunction in the first living hours in neonates with asphyxia: A randomized clinical trial study
effects of Aminophylline on renal function of neonates with moderate and severe perinatal asphyxia
Design
In this randomized clinical trial conducted from June 2016 until May 2017, for 12 months, 50 neonates that These were born with moderate to severe asphyxia during birth were enrolled. They were divided randomly by using random blocks into two groups of 25. The case group were administered one dose of 5mg/kg slow intravenous aminophylline injection during 5 minutes. The control group were administered 2 milliliters of intravenous 10% solution of dextrose saline as placebo with the same conditions as the case group.
Settings and conduct
Double-blinded randomized clinical trial in NICU of selected hospital of Iran university of medical science.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The neonates with moderate and severe perinatal asphyxia
Exclusion criteria: Congenital Anomalies; Prematurity (Gestational age≥37 week)
Intervention groups
The case group were administered one dose of 5mg/kg slow intravenous aminophylline injection during 5 minutes. The control group were administered 2 milliliters of intravenous 10% solution of dextrose saline as placebo with the same conditions as the case group
Main outcome variables
The neonates’ fluid intake, Urine volume in the first three days, serum electrolytes including Sodium, Potassium, Calcium, serum Creatinine and GFR were monitored. The two groups were also monitored and compared for complications of prenatal asphyxia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181201041815N1
Registration date:2019-01-15, 1397/10/25
Registration timing:retrospective
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Nasrin Khalessi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2041
Email address
khalesi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-06-22, 1396/04/01
Trial completion date
2017-06-22, 1396/04/01
Scientific title
Effect of intravenous Aminophylline injection on preventing renal dysfunction in the first living hours in neonates with asphyxia: A randomized clinical trial study
Public title
Effect of intravenous Aminophylline injection on preventing renal dysfunction
A randomized blocking method of four blocking was used using R statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants (neonate), researcher, therapist and the evaluator were informed of the allocation in the intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School Of Medicine,Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.IUMS.REC 1395.8821215173
Health conditions studied
1
Description of health condition studied
Recovery of moderate to severe asphyxia in newborns
ICD-10 code
R09.0
ICD-10 code description
Asphyxia and hypoxemia
Primary outcomes
1
Description
The neonates’ fluid intake
Timepoint
Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life
Method of measurement
Using Schwartz's formula, in two studied groups.
2
Description
Urine volume in the first three days,
Timepoint
Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life
Method of measurement
Using Schwartz's formula, in two studied groups.
3
Description
Serum electrolytes including Sodium, Potassium, Calcium, serum Creatinine
Timepoint
Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life
Method of measurement
Using Schwartz's formula, in two studied groups.
4
Description
GFR
Timepoint
Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life
Method of measurement
Using Schwartz's formula, in two studied groups.
Secondary outcomes
1
Description
Lung disease
Timepoint
During the 4th and 7th day of life
Method of measurement
Chest X ray
2
Description
Intra Ventricular Hemorrhages seizure
Timepoint
During the 4th and 7th day of life
Method of measurement
Brain sonography and nursing documentation related to seizure.
3
Description
Death
Timepoint
During the 4th and 7th day of life
Method of measurement
Shift documentation
Intervention groups
1
Description
Intervention group: were administered one dose of 5 mg/kg slow intravenous Aminophylline injection during 5 minutes.
Category
Treatment - Drugs
2
Description
Control group: The control group was administered 2 milliliters of intravenous 10% solution of dextrose saline as placebo with the same conditions as the case group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliasghar hospital
Full name of responsible person
Nasrin Khalessi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
nasrinkhalessi@yahoo.com
2
Recruitment center
Name of recruitment center
shahid Akbar-Abadi
Full name of responsible person
Nasrin Khalessi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
nasrinkhalessi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasrin Khalessi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nasrinkhalessi@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasrin Khalessi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nasrinkhalessi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasrin Khalessi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nasrinkhalessi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasrin Khalessi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nasrinkhalessi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data and documentation are arranged in separate files and after publishing the results ready to distribution.
When the data will become available and for how long
7-10 days
To whom data/document is available
Every body that will be re analyzed or meta-analyzed.
Under which criteria data/document could be used
In order to perform more robust statistical tests that may occur in the future. Or the person who intends to do meta-analysis.
From where data/document is obtainable
Aliasghar hospital- Neonatal Intensive Care Unit-Dr Nasrin khalessi-
What processes are involved for a request to access data/document
The demandant person will request Dr. Khalesi by email and the files will be sent to them.