Comparison of The effect of Aminophylline and Alloprinol in the treatment of neonates with asphyxia
Design
In the first hour, the first group received 5 mg / kg intravenous Aminophylline as a STAT and two hours after neonatal admission to the Neonatal Intensive Care Unit (NICU) with a maintenance dose of 1 mg / kg Aminophylline at a rate of 60-60 cc / kg / day every 12 They find the clock for a week.
The second group received 40 mg / kg Alloprinol daily for 7 days two hours after birth and hospitalized in the ward (NICU).
The control group received 5% dextrose volume.
Settings and conduct
All neonates with asphyxia admitted to the Neonatal Intensive Care Unit (NICU) of Shoushtar Hospital in 2019
Participants/Inclusion and exclusion criteria
Inclusion criteria (Apgar score less than 5 and cord artery pH less than 7.2) and Exclusion criteria based on AAP guideline (premature infants with congenital and chromosomal abnormalities and abnormalities of mother and gestational diabetes mellitus)
Intervention groups
They were randomly divided into group 30 (Aminophylline), group 30 (Alloprinol) and group 30 (control).
Main outcome variables
Kidney function (BUN and Cr)
Brain function (DRT index and reflexes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121229011923N7
Registration date:2019-12-23, 1398/10/02
Registration timing:prospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Akram Hematipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8302
Email address
hematipour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two drugs Alloprinol and Aminophylline in the treatment of neonates with asphyxia
Public title
Comparison of the effect of two drugs Alloprinol and Aminophylline in the treatment of neonates with asphyxia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
5 minute apgar less than 5
The pH of the cord artery is less than
Exclusion criteria:
Parental dissatisfaction
Premature infants with congenital and chromosomal abnormalities and renal and abdominal malformations
Mother with gestational diabetes
Age
From 1 day old to 1 day old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
It will be randomly selected and will consist of 4-person blocks using the block randomization method
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
کمیته اخلاق دانشکده علوم پزشکی شوشتر
Street address
Rajaee West Ave., Faculty of Medical Sciences Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
84534-64516
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.SHOUSHTAR.REC.1398.010
Health conditions studied
1
Description of health condition studied
Asphyxia
ICD-10 code
R09.01
ICD-10 code description
Asphyxia
Primary outcomes
1
Description
Improve kidney function
Timepoint
To evaluate the performance of all BUN, Cr and electrolyte measurements (Na and k) one day in between for one week
Method of measurement
Blood test
2
Description
Improve brain function
Timepoint
Daily
Method of measurement
The nervous system is also monitored daily by Moro, sucking, Grasping reflexes and the DTR index (deep tendon reflex). And if they are normal, we move one shot at a time, and we have the same direction with the muscle that we hit. Depending on the reflex we can score 4 (score 0): Under no circumstances can reflex be achieved, (+1 score): We can get reflex when the patient is distracted and reflex is reduced (+2 score) : The reflex is normal, (+3 score) when we have expansion at the point of insertion (reflex can also be achieved at other locations), (+4 score): when clonus This means that when a blow is made, the reflex is repeated several times, and the movement is repeated several times, with a score of 0 or 4 and 3 meaning a brain injury.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first hour, the first intervention group received 5mg / kg intravenous aminophylline as STAT and two hours after neonatal admission to the neonatal intensive care unit (NICU) 1mg / kg infusion with a maintenance dose of 65 -60cc / kg / day are found every 12 hours for a week.
Category
Treatment - Drugs
2
Description
Intervention group: Alloprinol 40 mg / kg daily for 7 days two hours after birth and in hospital (NICU) intravenously
Category
Treatment - Drugs
3
Description
Control group: Treatment will continue without any intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shoushtar Elahadi Hospital
Full name of responsible person
Akram Hemmatipour
Street address
West Rajaie Street
City
Shoushtar
Province
Khouzestan
Postal code
64516- 84534
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences Shoushtar
Full name of responsible person
Mojtaba Kalantar
Street address
Rajaee West Ave., Faculty of Medical Sciences Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
84534-64516
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences Shoushtar
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
Faculty of Medical Sciences Shoushtar
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaee West Ave., Faculty of Medical Sciences Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516-84534
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of medical Sciences Shoushtar
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of medical Sciences Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516- 84534
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences Shoushtar
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaee West Ave., Faculty of Medical Sciences Shoushtar
City
Shoushtar
Province
Khouzestan
Postal code
64516- 84534
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.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
no
When the data will become available and for how long
no
To whom data/document is available
no
Under which criteria data/document could be used
no
From where data/document is obtainable
no
What processes are involved for a request to access data/document