The effect of adding budesonide to surfactant on prevention of chronic pulmonary disease in premature infants less than 30 weeks
Design
A three phase clinical trial with one intervention group and one control group, in parallel groups, not blind, simple randomized, with coded card selection and with sample size of 190
Settings and conduct
In this study, a single-blind randomized controlled clinical trial. A total of 190 preterm infants less than 30 weeks of age (95 patients in each group) were selected as the study population from the NICU ward of Alzahra and Shahid Beheshti Hospitals in Isfahan and the effect of addition of budesonide to lung-injected surfactant Surfactants alone are being studied to reduce the risk of chronic lung disease (CLD).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants with pre-existing GA <30 weeks admitted to the NICU; Receives some kind of non-invasive respiratory support including CPAP and physician decides to prescribe surfactant; Exclusion criteria: Major congenital anomalies affecting neonatal respiration (severe pulmonary hypoplasia, congenital lung abnormality, congenital airway obstruction); Asphyxia; Gastrointestinal anomalies that cause the baby to be transferred to another center; Sepsis before starting the study; Cyanotic heart disease
Intervention groups
Neonates are randomly divided into two groups of surfactant (S) and surfactant + budesonide (B) combination.
Main outcome variables
The time required for mechanical ventilation; The period of time of no need for non-invasive ventilation; Duration of hospital stay; The period of time of Surfactant injections, The condition of chronic lung disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N38
Registration date:2020-05-08, 1399/02/19
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-01-16, 1399/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Budesonide plus Surfactant in prevention of chronic lung disease in premature infants with gestational age less than 30 weeks
Public title
Effect of Budesonide with Surfactant on the prevention of chronic lung disease in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with pre-existing GA <30 weeks admitted to the NICU
Receives some kind of non-invasive respiratory support including CPAP and physician decides to prescribe surfactant
Exclusion criteria:
Major congenital anomalies affecting neonatal respiration (severe pulmonary hypoplasia, congenital lung abnormality, congenital airway obstruction)
Asphyxia
Gastrointestinal anomalies that cause the baby to be transferred to another center
Sepsis before starting the study
Cyanotic heart disease
Age
To 7 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, simple randomization with individual unit is used, so that patients randomly select one of the cards containing the codes A or B so they enter one of the two treatment groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.MUI.MED.REC.1398.507
Health conditions studied
1
Description of health condition studied
Chronic lung disease
ICD-10 code
P27.8
ICD-10 code description
Other chronic respiratory diseases originating in the perinatal period
Primary outcomes
1
Description
The time required for mechanical ventilation
Timepoint
4 to 6 weeks after birth
Method of measurement
Check list
2
Description
The period of time of no need for non-invasive ventilation
Timepoint
4 to 6 weeks after birth
Method of measurement
Check list
3
Description
Duration of hospital stay
Timepoint
4 to 6 weeks after birth
Method of measurement
Check list
4
Description
The period of time of surfactant injections
Timepoint
4 to 6 weeks after birth
Method of measurement
Check list
5
Description
The condition of chronic lung disease
Timepoint
4 to 6 weeks after birth
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Babies in need of surfactant receive exogenous surfactant + budesonide solution 0.25 mg / kg or 0.5 cc / kg which is injected into the face via an intratracheal catheter. Each infant is given only one dose of budesonide.
Category
Treatment - Drugs
2
Description
Control group: Infants who need surfactants receive exogenous surfactants which are injected into the face via an intratracheal catheter.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Amir-Mohammad Armanian
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3625 5555
Email
armanian@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Beheshti
Full name of responsible person
Amir-Mohammad Armanian
Street address
Motahari St., Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3625 5555
Email
armanian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir-Mohammad Armanian
Position
Associate Professor of Neonatal-Perinatal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Isfahan Medical School, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
0098 31 6255555
Email
armanian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir-Mohammad Armanian
Position
Associate Professor of Neonatal-Perinatal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Isfahan Medical School, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
0098 31 6255555
Email
armanian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir-Mohammad Armanian
Position
Associate Professor of Neonatal-Perinatal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Isfahan Medical School, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
0098 31 6255555
Email
armanian@med.mui.ac.ir
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