Effectiveness of surfactant administration in two different methods (MIST, INSURE) on the short-term outcome of preterm infants with respiratory distress syndrome: a randomized clinical trial
Effectiveness of surfactant administration in two different methods (MIST, INSURE) on the short-term outcome of preterm infants with respiratory distress syndrome
Design
A clinical trial with a control group, parallel, randomized groups, phase 3 on 80 patients, by block randomization method with blocks of ten, according to the block randomization protocol produced by Random Allocation Software.
Settings and conduct
This study is conducted in patients with respiratory distress syndrome in the neonatal intensive care unit of Rouhani Hospital
Participants/Inclusion and exclusion criteria
All live births with a gestational age of 28 to 34 weeks who need surfactant administration according to clinical and radiographic conditions.
Intervention groups
The control group is treated with surfactant by the Insure method and the intervention group is treated with surfactant by the mist method.
Main outcome variables
Determining and comparing the duration of CPAP respiratory support in the MIST group with the INSURE group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240602061980N1
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Samira Pournajaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
s.pournajaf@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-11, 1403/03/22
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of surfactant administration in two different methods (MIST, INSURE) on the short-term outcome of preterm infants with respiratory distress syndrome: a randomized clinical trial
Public title
comparison of MIST and INSURE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all live births with a gestational age of 28 to 34 weeks who were born in Ayatollah Rouhani Hospital, Babol, and had clinical symptoms of respiratory distress syndrome.
To assign the target group to one of the two study groups; The MIST group and the INSURE group (two groups A and B) will use the Block Randomization method with ten blocks. According to the block randomization protocol (produced by Random Allocation Software), they will be assigned to one of two groups with a ratio of 1:1, so that the researcher cannot predict which group the next person will be in. .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province,IR Iran.
City
Babol
Province
Mazandaran
Postal code
47317-41151
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.MUBABOL.REC.1403.028
Health conditions studied
1
Description of health condition studied
respiratory distress syndrom( RDS)
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system(J00-J99);certain conditions originating in the perinatal period (P00-P96);J95-J99 Other diseases of the respiratory system
Primary outcomes
1
Description
Determining and comparing the duration of CPAP respiratory support in the MIST group with the INSURE group
Timepoint
The duration of CPAP respiratory support is determined in hours
Method of measurement
time
Secondary outcomes
1
Description
Determining and comparing the need for surfactant re-administration in the MIST group with the INSURE group
Timepoint
in 12 hour
Method of measurement
Decision making based on the patient's clinical conditions and remaining respiratory distress and the need for high fio2
2
Description
Determining and comparing the frequency of pneumothorax in the MIST group with the INSURE group
Timepoint
during hospitalization period
Method of measurement
chest x-ray
3
Description
Determining and comparing the frequency of the need for mechanical ventilation in the MIST group with the INSURE group
Timepoint
Within 72 hours of treatment
Method of measurement
mechanical ventilator
4
Description
Determining and comparing the frequency of pulmonary haemorrhage in the MIST group with the INSURE group
Timepoint
during hospitalization
Method of measurement
chest x ray or significant bleeding from the tracheal tube
Intervention groups
1
Description
Intervention group:This group receives intratracheal surfactant by the MIST( minimal invasive surfactant therapy) method.In this method, when the baby is under CPAP, a thin 6f tube is inserted into the trachea through a direct laryngoscope, and without PPV pressure, surfactant is administered into the lungs.
Category
Treatment - Other
2
Description
Control group:This group receives intratracheal surfactant by the INSURE ( INtubation, SUREfactant administration, Extubation) method.In this method, the baby is intubated with a size 3 endotracheal tube, with direct laryngoscopy, and surfactant is administered into the lungs using another thin tube that is placed inside the endotracheal tube and is administered with PPV pressure.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah ruhani hospital
Full name of responsible person
samira pournajaf
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
47317-41151
Phone
+98 11 3232 0443
Email
s.pournajaf@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
mehdi rajabnia
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3232 0443
Email
samirapournajaf@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Samira Pournajaf
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, 47317-41151, IR Iran.
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3232 0443
Email
s.pournajaf@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samira Pournajaf
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, 47317-41151, IR Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۳۱۷۴۱۱۵۱
Phone
+98 11 3234 6963
Fax
Email
s.pournajaf@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samira Pournajaf
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Shafa St, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, 47317-41151, IR Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۳۱۷۴۱۱۵۱
Phone
+98 11 3234 6963
Fax
Email
s.pournajaf@mubabol.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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
the data will become available 1 month after publication
To whom data/document is available
The data will be available to all researchers in the medical field
Under which criteria data/document could be used
Any research that has a code of ethics can be done
From where data/document is obtainable
Applicants can send their application to the email address of the responsible person
What processes are involved for a request to access data/document
Applicants can send their request to the responsible executive and data will be provided to them within a month