Comparison of therapeutic effects of Iranian surfactant (Beraksurf) with Cursorf in premature infants with respiratory distress admitted to the neonatal intensive care unit of Hafez and Namazi hospitals in Shiraz in 1400
Determining the therapeutic effects of surfactant made in Iran (Beraksurf) compared to cursorf in treatment of neonates with respiratory syndrome admitted in neonatal intensive care unit in Hafez and Namazi hospital
Design
A randomized clinical trial with parallel two intervention groups (1 and 2), single blinded, randomized, N= 100 patients (each group N= 50) and phase 2. Block randomization will be used for randomization.
Settings and conduct
This research includes preterm neonates, admitted to Hafez or Namazi hospital who need receiving surfactant. Then beraksurf or cursorf is given. Blinding in this research is single-blind and parents do not know their neonate is in which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age less than 37 weeks, the clinical or radiologic signs of respiratory distress syndrome, need Fio2 more than 30% in the first 6hour of life to keep saturation 92-95%.
Exclusion criteria: congenital disease or anomalies, receiving two types of surfactant, neonates who need an operation, neonates with congenital heart or lung disease, or abdominal pathology.
Intervention groups
The first group consists of neonates receiving Beraksurf and the second group of neonates receiving Cursorf due to respiratory distress syndrome.
Main outcome variables
Need a ventilator; O2 saturation rate; Sepsis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120126008827N3
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Khadijeh Sadat Najib
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4298
Email address
nzahrasan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of Iranian surfactant (Beraksurf) with Cursorf in premature infants with respiratory distress admitted to the neonatal intensive care unit of Hafez and Namazi hospitals in Shiraz in 1400
Public title
Evaluation of the effect of Beraksurf and Cursorf in patients with respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age < 37 weeks
Radiologic and clinical diagnosis during first 6 hours,
Need to Fio2>30% for keeping o2 saturation 92-95% that measured by pulse oximetry
Exclusion criteria:
Patients with congenital disease and anomalies
Receiving two types of surfactant due to lack or shortage of the drug
Patients need operation
Neonates with congenital heart or lung disease or abdominal pathology
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
En In this study, we will use the limited randomization method of block randomization, which is used to balance the number of participants in each study group. The size of the blocks is equal, and we will have 50 participants in each group. For block randomization, the size of the blocks is considered to be five. According to the sample size, 20 blocks will be selected based on a table of random numbers. The individuals are assigned to groups based on the position of the blocks.
Random allocation concealment will be done using randomly sealed opaque envelopes. The random allocation sequence was computer-generated (Kendall and Smith's Random Numbers Table) by a statistician who was not a part of the research team. A random number table is a series of digits (0 to 9) arranged randomly in rows and columns, as demonstrated in the small sample below. The table usually contains 5-digit numbers, arranged in rows and columns, for ease of reading. The random allocation sequence was concealed in sealed opaque envelops until the participants were assigned into two groups participants were assigned into two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method in this study will be single-blind. The single-blind is used to reduce bias related to the intervention and evaluate the consequences. In this study, samples of the research are blinded (parents know about the study drugs, but they will not be informed about grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shiraz University of Medical Sciences, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.SUMS.REC.1400.569
Health conditions studied
1
Description of health condition studied
respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
treatment of respiratory distress syndrome
Timepoint
evaluate respiratory condition of neonates at birth and 2, 6,12,18,24,36,48 and 72 hour after birth
Method of measurement
Beraksurf case report form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, 50 neonates with RDS diagnosis will receive intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 2.5 cc/ kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, 50 neonates with RDS diagnosis will receive intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc/kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee hospital
Full name of responsible person
Khadijeh Sadat Najib
Street address
Nemazee square, Shiraz , Iran
City
Shiraz
Province
Fars
Postal code
71936133111
Phone
+98 71 3647 4298
Email
nzahrasan@yahoo.com
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Khadijeh Sadat Najib
Street address
Hafez hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Shiraz University of Medical Sciences, Zand steert, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5417
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Sadat Najib
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatal
Street address
Nemazee hospital, Nemazee square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 1647 4298
Fax
+98 71 1647 4298
Email
nzahrasan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Sadat Najib
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Nemazee hospital, Nemazee square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 1647 4298
Fax
+98 71 1647 4298
Email
nzahrasan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Sadat Najib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Nemazee hospital, Nemazee square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 1647 4298
Fax
+98 71 1647 4298
Email
nzahrasan@yahoo.com
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