Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD) compared with surfactant alone in the treatment of respiratory distress syndrome in preterm infants.
Comparison of the effect of concomitant endotracheal administration of surfactant and budesonide with surfactant alone in preventing bronchopulmonary dysplasia in preterm infants
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 296 patients.A random list will be prepared by visiting the sealed envelope site.
Settings and conduct
Premature infants hospitalized in Hazrat Rasoul Akram and Shahid Akbarabadi hospitals in Tehran will be included in the study.The grouping is in a sealed envelope and is opened by the pharmacy, and the doctor receives the medicine in a syringe that has been drawn and is ready for injection and injects it into the trachea. The relevant nurse and physician who fill the checklist will not be aware of the baby's grouping.In the control group, an initial dose of Braksurf is injected into the trachea. In the intervention group, in addition to Braksurf, budesonide is injected into the trachea.
Participants/Inclusion and exclusion criteria
Admission requirements:
Premature infants with a gestational age less than 37 weeks and weighing less than 1,500 g ; and requires a surfactant injection at the physician's discretion.
Exclusion requirements :
-Congenital major anomalies
-Asphyxia
-Parental dissatisfaction
Intervention groups
Intervention group: Simultaneous intratracheal injection of surfactantand and budesonide
Control group: Surfactant injection
Main outcome variables
Need for additional dose of surfactant; Duration of need for mechanical ventilation; Duration of need for non-invasive ventilation; Duration of need for hospitalization; Bronchopulmonary dyspasia incidence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211107052993N1
Registration date:2021-11-21, 1400/08/30
Registration timing:registered_while_recruiting
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
arezoo aminyan daryasari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4222 9638
Email address
a.aminyan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-10, 1400/08/19
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD) compared with surfactant alone in the treatment of respiratory distress syndrome in preterm infants.
Public title
Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with a Gestational age less than 37 weeks
weighing less than 1,500 g
Premature infants admitted to the Neonatal ward due to Respiratory distress syndrome based on clinical and radiological symptoms and negative blood culture at birth; And receives any non-invasive respiratory support, and requires a surfactant injection at the physician's discretion.
Exclusion criteria:
Congenital major anomalies that affect the baby's breathing
Existence of asphyxia; (Apgar score less than 7 in 5 minutes of birth)
Parental dissatisfaction
Gastrointestinal abnormalities that cause the baby to be transferred to another center
Congenital cyanotic heart disease
Age
To 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
296
Randomization (investigator's opinion)
Randomized
Randomization description
Premature infants with symptoms of Respiratory Distress Syndrome are randomly assigned to one of two groups of control (surfactant) or intervention (surfactant plus budesonide) according to random numbers extracted from the computer. To assign each person to the study arms, a random list will be prepared by visiting the sealed envelope site. This site allows us to have a random list at the beginning of the study to assign people to study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed written consent from the parents of premature infants with symptoms of Respiratory Distress Syndrome, they are randomly assigned to one of two groups of control (surfactant) or intervention (surfactant plus budesonide) according to random numbers extracted from the computer. The grouping is in a sealed envelope and is opened by the pharmacy, and the doctor receives the medicine in a syringe that has been drawn and is ready for injection and injects it into the trachea. The relevant nurse and physician who records the patient information checklist will not be aware of the baby's grouping. The doctor involved in the treatment of infants does not know the grouping of infants.
Placebo
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
Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.IUMS.FMD.REC.1400.165
Health conditions studied
1
Description of health condition studied
Bronchopulmonary dysplasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
2
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
Bronchopulmonary dysplasia
Timepoint
daily , end of 6 week or discharge time
Method of measurement
clinical
2
Description
duration of auxiliary oxygen reception
Timepoint
daily , end of 6 week or discharge time
Method of measurement
clinical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Simultaneous intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight) and budesonide (budesonide at a dose of 0.25 mg / kg body weight)
Category
Prevention
2
Description
Control group: intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Arezoo Aminyan
Street address
Shahid Akbarabadi Medical Training Center, Ferdows Garden Station, Molavi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
Email
akbarabadihosp@yahoo.com
2
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Arezoo Aminyan
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., corner of Mansouri Kia St., Sattarkhan neighborhood, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasulhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
leyla irani
Street address
Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
iumspr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Arezoo Aminyan daryasari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Naft building 264, Zafar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1918613436
Phone
+98 13 4222 9638
Fax
Email
a.aminyan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arezoo Aminyan daryasari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Naft building 264, Zafar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1918613436
Phone
+98 13 4222 9638
Fax
Email
a.aminyan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arezoo Aminyan daryasari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Naft building 264, Zafar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1918613436
Phone
+98 13 4222 9638
Fax
Email
a.aminyan@yahoo.com
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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Sharing information about the main outcome
When the data will become available and for how long
6 months after publication
To whom data/document is available
Physicians working in scientific and academic institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
a.aminyan@yahoo.com
What processes are involved for a request to access data/document