A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome with a gestational age of less than 32 weeks
A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome
Design
This is a randomized, single-blinded clinical trial with a parallel design. This randomized study will be conducted on 58 premature babies with respiratory distress. A random block is used for randomization and the participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah, is a single-blinded study. Surfactant injection at a dose of 100 mg/kg will be done through intrapulmonary intubation under sterile conditions and as instillation into the tube, and after instilling the surfactant, the baby will be ventilated and the tracheal tube will be removed and the baby will be treated with NCPAP or HFNC (INSURE).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature babies less than 32 weeks with respiratory distress syndrome; Infants who need surfactant
Exclusion criteria: Existence of other respiratory diseases other than respiratory distress syndrome; Congenital heart abnormalities; A history of resuscitation at birth with severe metabolic vasculitis
Intervention groups
In the first intervention group, in the first 12 hours after birth, they will receive the manufactured Berketant surfactant (manufactured byTekzima, Iran), an 8cc vial prepared from pig lungs. The second intervention group will receive Corosurf surfactant (manufactured by Cheisi, Italy) in a 3 cc vial prepared from pig lungs in the first 12 hours after birth.
Main outcome variables
Duration of NICU stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N210
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome with a gestational age of less than 32 weeks
Public title
A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature babies less than 32 weeks with respiratory distress syndrome
Infants who need surfactant
Exclusion criteria:
Existence of other respiratory diseases other than respiratory distress syndrome
Congenital heart abnormalities
A history of resuscitation at birth with severe metabolic vasculitis
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
Blinding (investigator's opinion)
Single blinded
Blinding description
Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.KUMS.MED.REC.1402.061
Health conditions studied
1
Description of health condition studied
Distress syndrome of neonates
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of NICU stay
Timepoint
End of study
Method of measurement
Based on the hospitalization record
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, in the first 12 hours after birth, they will receive the manufactured Berketant surfactant (manufactured byTekzima, Iran), an 8cc vial prepared from pig lungs
Category
Treatment - Drugs
2
Description
The second intervention group will receive Corosurf surfactant (manufactured by Cheisi, Italy) in a 3 cc vial prepared from pig lungs in the first 12 hours after birth.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam Reza Beigi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
maryamrezabeigi1358@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Reza Beigi
Position
Resident of Pediatric
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
maryamrezabeigi1358@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Noushin Miladi
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
maryamrezabeigi1358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Reza Beigi
Position
Resident of Pediatric
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
maryamrezabeigi1358@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