Comparison of the combined effect of budesonide and surfactant with surfactant alone in the treatment of respiratory distress syndrome and prevention of bronchopulmonary dysplasia
The study investigates the impact of budesonide and surfactant on treating Respiratory Distress Syndrome (RDS) and preventing Bronchopulmonary Dysplasia (BPD) in preterm infants
Design
A double-blind randomized clinical trial
Settings and conduct
The study will be conducted at Fatemieh Hospital in Hamadan, where patients will be randomly assigned to two groups: one receiving budesonide and surfactant and the other receiving surfactant alone. The design of the study will be a double-blind randomized trial
Participants/Inclusion and exclusion criteria
The study included preterm infants with a gestational age of 32 weeks or less and a birth weight of less than 1500 grams, all diagnosed with Respiratory Distress Syndrome (RDS) who required surfactant therapy. Exclusion criteria encompassed infants with major congenital anomalies, congenital heart disease (excluding atrial septal defect and patent ductus arteriosus), those experiencing asphyxia (Apgar score less than 4 at 5 minutes post-birth), evidence of necrotizing enterocolitis prior to surfactant administration, chromosomal disorders, heart failure requiring treatment, shock, esophageal atresia, and diaphragmatic hernia
Intervention groups
The study focuses on preterm infants born via natural delivery or cesarean section, with a gestational age of 26 to 32 weeks and a birth weight of less than 1500 grams, who are admitted to the NICU at Fatemieh Hospital in Hamadan due to a diagnosis of Respiratory Distress Syndrome (RDS) and have an indication for surfactant therapy
Main outcome variables
valuating the improvement in respiratory distress and oxygen dependency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241116063727N1
Registration date:2024-11-30, 1403/09/10
Registration timing:registered_while_recruiting
Last update:2024-11-30, 1403/09/10
Update count:0
Registration date
2024-11-30, 1403/09/10
Registrant information
Name
Hanieh Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 8850
Email address
talebi_hanieh@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-30, 1403/09/10
Expected recruitment end date
2025-05-31, 1404/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the combined effect of budesonide and surfactant with surfactant alone in the treatment of respiratory distress syndrome and prevention of bronchopulmonary dysplasia
Public title
The effect of budesonide and surfactant in the treatment of respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All preterm babies with birth age less than 32 weeks provided they have respiratory distress syndrome (RDS) There is evidence of RDS in chest X-ray and ABG and they are candidates to receive surfactant Babies born at the hip less than 24 weeks of pregnancy - with a birth weight of less than 400 grams - the presence of congenital cardiopulmonary disease - conditions for not entering the study
Exclusion criteria:
Major Congenital Anomaly: Congenital heart disease excluding atrial septal defect and patent ductus arteriosus, in newborns experiencing asphyxia (Apgar score less than 4 at 5 minutes post-birth), evidence of necrotizing enterocolitis prior to surfactant administration, presence of major congenital anomalies, chromosomal disorders, heart failure requiring treatment, shock, esophageal atresia, and diaphragmatic hernia
Age
From 1 day old to 90 days old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block randomization method will be used to allocate patients into study blocks. Initially, participants will be randomly divided into two groups, A and B, using blocks of four. Two pieces of paper labeled "A" and two pieces labeled "B" will be placed into a bag and mixed. For each participant entering the study, one piece of paper will be drawn from the bag, and based on the label on the paper, the patient will be assigned to one of the two groups (Group A: combination treatment; Group B: treatment with surfactant alone). After ten patients, the papers will be returned to the bag, and this process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
infants don't know the used drugs. clinical manager administer prepared drug according patients code. outcome is recorded by a nurse who is not aware administered drugs . researcher is blind about patients groups and records data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Fahmideh
City
hamedan
Province
Hamadan
Postal code
6517997178
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.UMSHA.REC.1403.581
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
Primary outcomes
1
Description
BPD (Bronchopulmonary Dysplasia) is classified into three severity categories based on the need for oxygen support at 36 weeks of gestational age: Mild BPD indicates that infants do not require any supplemental oxygen; Moderate BPD means infants need less than 30% oxygen; and Severe BPD refers to infants requiring 30% oxygen or more, with or without positive pressure ventilation at 36 weeks of gestation.
Timepoint
Daily for the first three days of life, and for three days after the intervention, and 30-42 days later."
Method of measurement
Clinical Examination
Secondary outcomes
1
Description
Bronchopulmonary Dysplasia (BPD) is classified into three severity levels: Mild BPD refers to infants who do not require oxygen at 36 weeks of gestational age. Moderate BPD is characterized by infants needing less than 30% oxygen at the same gestational age. Severe BPD involves infants requiring 30% oxygen or more, which may include the use of positive pressure ventilation or continuous positive airway pressure (CPAP) at 36 weeks of gestational age. This classification helps in determining the management and care required for affected infants.
Timepoint
28 days later
Method of measurement
Clinical examination
Intervention groups
1
Description
Premature infants who meet the eligibility criteria for the study are included in the study through convenience sampling and are randomly assigned to treatment with budesonide and surfactant or surfactant alone.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital
Full name of responsible person
Mohammad kaze Kazem Sabzehei
Street address
Pasdaran
City
Hamedan
Province
Hamadan
Postal code
6517997178
Phone
+98 918 812 8458
Email
mk_sabzehei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Talebi
Street address
Sarvestan
City
Hamedan
Province
Hamadan
Postal code
6515961137
Phone
+98 911 254 8275
Email
Talebi_hanieh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Talebi
Position
دستیار فوق تخصص نوزادان
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sarvestan
City
Hamedan
Province
Hamadan
Postal code
6515961137
Phone
+98 81 3823 8850
Email
Talebi_hanieh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Talebi
Position
دستیار فوق تخصص نوزادان
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sarvestan
City
Hamedan
Province
Hamadan
Postal code
6515961137
Phone
+98 81 3823 8850
Email
Talebi_hanieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Talebi
Position
Neonatology Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sarvestan
City
Hamedan
Province
Hamadan
Postal code
6515961137
Phone
+98 81 3823 8850
Email
Talebi_hanieh@yahoo.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