Determining the effect of using cold preservative serum on hypothermia in newborns with moderate to severe hypoxic ischemic encephalopathy
Design
They were divided into two groups: intervention and control. 50 samples were randomly divided into two groups. They were studied in the study.
Settings and conduct
Samples were selected from Imam Reza Hospital in Mashhad during 1396 to 1398 and a questionnaire was prepared using a blinded one that participants did not know how to do the plan.
Participants/Inclusion and exclusion criteria
Having written consent of parents after explaining and justifying them in the process of treatment and based on medical ethics standards, neonates with gestational age greater than 36 weeks and weighing more than 2500 grams have one of the following characteristics:
1) Apgar score less than 5 in 10 minutes after birth or need of the baby to continue the regenerative procedure (including ventilation with mask and intubation) until 10 minutes after birth or acidosis in the first hour after birth (PH in Cord blood or arterial blood or capillary blood is less than 7) or a base deficiency greater than 16 millimoles per liter in each of the blood samples in the first 60 minutes of birth
Intervention groups
Using the preserved serum to cool the temperature to 33-34 degrees Celsius in newborns with moderate to severe HIE that began at the first 6 hours of birth and continued until 72 hours after birth and then gradually warmed up The baby is between 8 and 12 hours to reach normal body temperature
In the control group, newborns with moderate to severe HIE status are under current and current treatment in the neonatal intensive care units of the country without hypothermic treatment.
Main outcome variables
Creation of hypothermic therapy with central temperature 33 to 34 ° C using cold preservation serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190204042609N1
Registration date:2019-06-27, 1398/04/06
Registration timing:retrospective
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Mojtaba Adineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
saba671388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2019-04-21, 1398/02/01
Scientific title
The effect of using cold preservative serum on hypothermia in newborns with moderate to severe hypoxia ischemic encephalopathy
Public title
Use of cold preservative in inducing hypothermia of newborns with encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Apgar score less than 5 in 10 minutes after the birth or need of the baby to continue the regenerative process (including ventilation with mask and intubation) until 10 minutes after birth or acidosis in the first hour after birth (PH in umbilical cord or arterial blood and Or capillary blood less than 7) or a base deficiency greater than 16 millimoles / liter in any of the blood samples within 60 minutes of the first birth
Clinical manifestations of moderate to severe postpartum encephalopathy
Exclusion criteria:
Parental dissatisfaction at each stage of induction cooled therapy
The infant's center temperature reaches more than 38 degrees Celsius
Neonatal abnormalities require surgery
Newborns with obvious anomalies require immediate intervention such as cyanatoid heart disease
In case of possible complications of treatment, a newborn resuscitation, such as severe bradycardia associated with apnea
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done simply so that the subjects were divided into two groups a and b according to the computer software table. The subjects were selected in each study and control group and their data were recorded in a questionnaire and blinded as one of the subjects was not aware of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qureishi Building- Daneshgah Ave- Mashhad- Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.537
Health conditions studied
1
Description of health condition studied
ischemic hypoxic episma encephalopathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Infants with moderate to severe HIE
Timepoint
Duration 48 to 72 hours of birth
Method of measurement
Clinical-Biochemical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infants with moderate to severe HIE
Category
Treatment - Drugs
2
Description
Control group: Infants with moderate to severe HIE with conventional treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, MAshhad University of Medical Sciences
Full name of responsible person
Mojtaba Adineh
Street address
Ibn Sina Ave- Imam Reza Hospital- MAshhad University of Medical Sciences
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
saba671388@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mojataba Adineh
Street address
Daneshgah Ave- Ghoreyshi bul- Mashhad- Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
saba671388@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mojtaba Adineh
Position
أثخدشفخمخلهسف
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bahar Ave- Shams Al Shomous Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
saba671388@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mojtaba Adineh
Position
Neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bahar Ave- Shams Al shomous Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
saba671388@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mojtaba
Position
Adineh
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bahar Ave- Shams Al Shomous Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
nrc@mums.ac.ir
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
A part of the questionnaire information that relates to patient information is shared.
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Available to academic and academic researchers
Under which criteria data/document could be used
After publishing it as a paper for the public and researchers from academic medical institutions
From where data/document is obtainable
ISI and Google
What processes are involved for a request to access data/document
In search sites, the use of asphyxiant words of infants - hypothermia in newborns