Comparison of the Efficacy and Side-effects of Two Surfactants (Beraksurf, and Bles) in the Treatment of Respiratory Distress Syndrome among Preterm infants
Comparison of the Efficacy and Side-effects of Two Surfactants (Beraksurf, and Bles) in the Treatment of Respiratory Distress Syndrome among Preterm infants
In order to blind the analyzer, the data input form designed according to codding without recording the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
َAfzalipur hospital, next to Shahid Bahonar University, Imam Khomeyny high way
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.KMU.AH.REC.1400.012
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrom
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Improvement Respiratory distress syndrom
Timepoint
ّFrom beginning, Daily
Method of measurement
Physical examination
2
Description
Mortality
Timepoint
From birthing continuous to end of treatment
Method of measurement
Vital sign checking
3
Description
Patent dactus arteriosus
Timepoint
From birthing intermittent echo cardiography
Method of measurement
Echo cardiography
4
Description
Intra ventricular hemorrhage
Timepoint
From birthing intermittent brain sonography
Method of measurement
Brain sonography
5
Description
pulmonary hemorrhage
Timepoint
Daily
Method of measurement
Physical examination
6
Description
Pneumothorax
Timepoint
Daily
Method of measurement
Physical examination and chest x-ray
7
Description
Sepsis
Timepoint
From birthing intermittent
Method of measurement
Blood culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intratecal administration of Surfactant kind Bles, Immediately after birth, up to 72 hours later, by clinical examination or by X-ray with the diagnosis of acute respiratory distress, the first dose of the drug is injected, repeated 6 hours after the X-ray injection, and if necessary, re-injection up to a maximum Up to three times, the dose of the drug in each injection is 135 mg per kilogram of baby weight, equivalent to 5 cc per kilogram of baby weight, the active ingredient of the drug is Thostidil colin, and this drug is made in Canada.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intratecal administration of Surfactant kind Beraksorf, Immediately after birth, up to 72 hours later, by clinical examination or by X-ray with the diagnosis of acute respiratory distress, the first dose of the drug is injected, repeated 6 hours after the X-ray injection, and if necessary, re-injection up to a maximum Up to three times, the dose of the drug in each injection is 100 mg per kilogram of baby weight, equivalent to 4 cc per kilogram of baby weight, the active ingredient of the drug is Thostidil colin, and this drug is made in IRAN by Tekzima co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Kerman hospital
Full name of responsible person
Mahdie Eslamian
Street address
Afzalipour hospital, Next to Shahid Bahonar University, Imam Khomaini high way
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
info@ah.kmu.ac.ir
Web page address
http://ah.kmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpur Afshar
Street address
Afzalipour Hospital, Next to Shahid bahonar university, Imam Khomainy High way
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
Info@Ah.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahdie Eslamian
Position
Flowship of Neonatology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Afzaly pour hospital, Next to Shahid bahonar university, Imam Khomayni high way
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
m.eslamian84@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdie Eslamian
Position
Flow ship neonatology
Latest degree
Specialist
Other areas of specialty/work
Occupational Therapy
Street address
No. 29, 31th Ave, maleke ashtar (shomaly)
City
Kerman
Province
Kerman
Postal code
7617777819
Phone
+98 34 3252 4893
Fax
Email
m.eslamian84@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdie Eslamian
Position
Flowship of Neonatology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Afzaly pour hospital, Next to Shahid bahonar university, Imam Khomayni high way
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
m.eslamian84@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available