comparison of the effects of surfactant with and without budesonide on the outcomes of respiratory distress syndrome in infants with a gestational age less than 32 weeks
Comparing the effect of surfactant with and without budesonide on respiratory distress syndrome in newborns
Design
This study will be a randomized clinical trial type. Premature infants with a gestational age of less than 32 weeks born in 1402 in the neonatal intensive care unit of Afzalipur Hospital, Kerman, who were admitted with respiratory distress syndrome and met the inclusion criteria and need to inject surfactant, they will be included in the study.The sample size in each case and control group will be 30 infants and this study is a double-blind study.This study is a phase 3 trial.
Settings and conduct
A control group will receive surfactant The initial dose will be 4 cc per kilogram of body weight from Braksurf brand.An intervention group will receive budesonide with a dose of 0.25 mg in addition to surfactant with the same dose.This study was conducted in a double-blind manner in the neonatal intensive care unit of Afzalipur Hospital in Kerman.The data was collected using a checklist and with the presence of the main researcher during the study stages.
Participants/Inclusion and exclusion criteria
neonates with a gestational age less than 32 weeks with neonatal respiratory distress syndrome
Intervention groups
Hospitalized infants with respiratory distress syndrome with a gestational age of 32 weeks or less
Main outcome variables
Necrotizing enterocolitis, pneumothorax, intraventricular hemorrhage, gastrointestinal bleeding, need for inotrope,The need for the second and third dose of surfactant, duration of invasive and non-invasive ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053444N3
Registration date:2024-04-06, 1403/01/18
Registration timing:retrospective
Last update:2024-04-06, 1403/01/18
Update count:0
Registration date
2024-04-06, 1403/01/18
Registrant information
Name
Zahra Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8198
Email address
z.jamali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effects of surfactant with and without budesonide on the outcomes of respiratory distress syndrome in infants with a gestational age less than 32 weeks
Public title
camparison of the effects of surfactant with and without budesonide on the outcomes of neonatal respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
neonates with respiratory distress syndrome with a gestational age of less than 32 weeks
Exclusion criteria:
severe asphyxia
Severe congenital anomalies
shock
Cardiovascular instability
Lack of parental consent
Maternal chorioamnionitis
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule will be used for random allocation.For this purpose, the number of 60 infants are randomly placed in the lottery container on the cards that were assigned to two groups.Each card is randomly drawn from the container without replacement and assigned to eligible infants who enter the study.In this way, 30 babies were divided equally in each study group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know the type of medicine received.Clinical caregivers will inject the medicine prepared in the syringe based on the patient's code.Also, the outcome evaluator will complete the checklist based on the patient's evaluation without knowing the received medicine.The principal investigator of the study will collect the checklist and record the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Imam Khomeini Boulevard, next to Bahonar University
City
kerman
Province
Kerman
Postal code
7616913355
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.KMU.AH.REC.1402.156
Health conditions studied
1
Description of health condition studied
Neonatal respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
The severity of respiratory distress at birth, which requires surfactant injection based on the respiratory score of newborns
Timepoint
1،2،3،4،5،6،7،8،9،10 day
Method of measurement
Infants respiratory score
Secondary outcomes
1
Description
necrotizing enterocolitis:infants who suffer from intestinal wall edema and feeding intolerance
Timepoint
1،2،3،4،5،6،7،8،9،10 days
Method of measurement
view
2
Description
Intraventricular hemorrhage
Timepoint
1،2،3،4،5،6،7،8،9،10 days
Method of measurement
Brain ultrasound
3
Description
pneumothorax
Timepoint
1،2،3،4،5،6،7،8،9،10 days
Method of measurement
lung radiography
4
Description
Duration of mechanical ventilation
Timepoint
1،2،3،4،5،6،7،8،9،10 days
Method of measurement
view
5
Description
sepsis
Timepoint
1،2،3،4،5،6،7،8،9،10 days
Method of measurement
blood culture
Intervention groups
1
Description
Intervention group: Premature infants hospitalized with a gestational age less than 32 weeks with neonatal respiratory distress syndrome that severity of their respiratory distress was such that they needed to receive surfactant based on the opinion of the attending physician.In addition to surfactant, this group of infants also received intrapulmonary budesonide at a dose of 0.25 mg per kilogram of body weight.
Category
Treatment - Drugs
2
Description
Control group: Premature infants hospitalized with a gestational age of less than 32 weeks, who, according to the doctor's opinion, needed to receive surfactant. This group only received surfactant alone at a dose of 4 cc per kilogram of body weight from braksurf brand.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur Kerman Hospital
Full name of responsible person
Zahra Jamali
Street address
Imam Khomeini Boulevard, Next to Bahnar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Imam Khomeini Boulevard, Next to Bahnar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Leila Sharifi
Position
Neonatal specialist assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini St., Next to Bahnar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
dinaleyla695@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
Neonatalogist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini St., Next to Bahnar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leila Sharifi
Position
Neonatal Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini St., Next to Bahonar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
dinaleyla695@gmail.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