Comparison of efficacy & safety of intratracheal Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)
Design
A randomized clinical trial (using permuted block), single blinded, with parallel 3 groups, N= 30 patients (each group N= 90), Phase 4
Settings and conduct
This interventional study will conducted from Jan 2019 to June 2020. 90 preterm neonate with diagnosis of RDS admitted in PICU of Akbar Abadi Hospital Tehran were selected. Neonates are randomly assigned to three groups. In the first intervention group, intratracheal Beraksurf (produced by Tekzima, Iran) is given every 6-12 hours at a dose of 4 cc / kg until the Fio2 is less than 30%. In the second intervention group, intratracheal Survanta (produced by ABBOT, US) every 6-12 hours at a dose of at a dose of 4 cc / kg until the Fio2 is less than 30%. In the third intervention group, intratracheal Curosurf (produced by chiesi, Italy) every 6-12 hours at a dose of at a dose of 4 cc / kg until the Fio2 is less than 30%. in this study only neonates are blind.
Participants/Inclusion and exclusion criteria
Parents consent to participate study
premature neonates with a gestational age of less than 34 weeks
premature neonates with diagnosis of RDS and candidates for surfactant
A maximum of 8 hours have elapsed since the birth
Intervention groups
No parents consent to participate study
Newborns with congenital heart diseases and other life threatening congenital anomalies.
Adverse drug effects
Main outcome variables
Improved outcomes in RDS (before intervention and after intervetion)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200529047594N1
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Niknaz Kabiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
kabiri.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-22, 1398/11/02
Expected recruitment end date
2020-06-22, 1399/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy & safety of intratracheal Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)
Public title
Comparison of efficacy & safety of Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parents consent to participate study
premature neonates with a gestational age of less than 34 weeks
premature neonates with diagnosis of RDS and candidates for surfactant
A maximum of 8 hours have elapsed since the birth
Exclusion criteria:
No parents consent to participate study
Newborns with congenital heart diseases and other life threatening congenital anomalies.
Adverse drug effects
Age
From 1 day old to 2 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Newborns are assigned to three groups: bracsurf (group A), survanta (group B) and Curosurf (group c). There are six possible block sequences of block size 3. Possible combinations include ABC, ACB, BAC, BCA, CAB, CBA.
Initially, one of the compounds is randomly selected, and 3 individuals are assigned to each block. This process is repeated many times to include the eligible sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, samples of the research are blinded (parents know about the study drugs, but they will not be informed about grouping A, B & c).
Placebo
Not 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
Hemat Highway, Next to the Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.548
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome (RDS)
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
improved outcomes in RDS
Timepoint
Before intervention and after intervention
Method of measurement
the need for mechanical ventilation, Venous Blood Gas
2
Description
Mortality
Timepoint
During the hospital stay
Method of measurement
Dead / alive
3
Description
Drug-related complications
Timepoint
During the hospital stay
Method of measurement
Yes/No
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%.
Category
Treatment - Drugs
2
Description
Intervention group 2: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Survanta (produced by ABBOT, US) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%.
Category
Treatment - Drugs
3
Description
Intervention group 3: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar-Abadi Hospital
Full name of responsible person
Niknaz Kabiri
Street address
Molavi Ave, Sjahid AkbarAbadi Hospital.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kabiri.n@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motevalian
Street address
Hemat Highway, Next to the Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5003
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Niknaz Kabiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
kabiri.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Kalani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Molavi Ave, AkbarAbadi Hospital.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kalani.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Niknaz Kabiri
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
kabiri.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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