Comparison of two methods of endotracheal tube and thin catheter for surfactant therapy in neonates with respiratory distress syndrome in neonatal intensive care unit
Design
A randomized clinical trial with parallel two intervention groups (1 and 2), single blinded, randomized, N= 80 neonates
Settings and conduct
This research includes preterm neonates, admitted to hospitals affiliated to Shiraz University of Medical Sciences who need receiving surfactant. Blinding in this research is single blind and statistical analyzer does not know neonate is in which group
Participants/Inclusion and exclusion criteria
inclusion criteria: Infants born with a gestational age of 25 to 37 weeks
Admitted to the neonatal intensive care unit (NICU)
exclusion criteria:Respiratory distress due to cardiac causes, hemodynamic instability, sepsis and any cause other than surfactant deficiency
Intervention groups
In this study, the first group will receive surfactant by Intubation-Surfactant-Extubation (INSURE) and Endo tracheal tube (ETT) method and the second group will receive surfactant by minimally invasive surfactant therapy (MIST) technique
Main outcome variables
Duration of need for mechanical ventilation; Duration of Nasal continuous positive airway pressure (NCPAP) requirement; amount of FiO2 required after receiving the surfactant; Bronchopulmonary Dysplasia (BPD) prevalence; Need to prescribe a second dose of surfactant
General information
Reason for update
Acronym
RDS: respiratory distress syndrome
IRCT registration information
IRCT registration number:IRCT20211006052685N2
Registration date:2022-07-12, 1401/04/21
Registration timing:retrospective
Last update:2022-07-12, 1401/04/21
Update count:0
Registration date
2022-07-12, 1401/04/21
Registrant information
Name
mehrdad rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 2218
Email address
md_rezaie@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of endotracheal tube and thin catheter for surfactant therapy in neonates with respiratory distress syndrome in NICU
Public title
Comparison of endotracheal tube and thin catheter for surfactant therapy in neonates with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants born with a gestational age of 25 to 37 weeksA
dmitted to the NICU
Exclusion criteria:
Respiratory distress due to cardiac causes
hemodynamic instability
sepsis and any cause other than surfactant deficiency
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each group. The number of samples assigned to each group is equal, and we will have 80 participants in each group. The size of all blocks is equal, and in this two-group experiment, we will have 10 blocks (including 8 participants in the intervention group and 8 participants in the control group). The drug will then be given to patients based on the blocks obtained and in the order of allocation. For randomization, it also uses random allocation software that this random sequence generation software, in addition to simple randomization, can generate a random sequence by blocking method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method in this study will be single-blind. The single-blind is used to reduce bias related to the intervention and evaluate the consequences. In this study, the data analyzer will not be informed about grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shiraz university of medical sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ ۷۱۳۴۸
Approval date
2022-01-04, 1400/10/14
Ethics committee reference number
IR.SUMS.MED.REC.1400.509
Health conditions studied
1
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
Treatment of respiratory distress syndrome
Timepoint
Evaluate respiratory condition of neonates at birth up to 30 days after birth
Method of measurement
Evaluate the duration and amount of need for mechanical ventilation, NCPAP and FiO2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The first group will receive surfactant by INSURE and ETT method. Neonates in this group were first intubated, and then surfactant was administered to them through a suitable tracheal tube. For infants, surfactant was administered slowly through the endotracheal tube (ETT). The administration was stopped if the surfactant returned to the ETT or the patient showed signs of intolerance. Patients were extubated immediately after finishing surfactant administration through INSURE. The dosage of surfactant in this method was also 100 mg/kg
Category
Treatment - Drugs
2
Description
Intervention group 2:In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The second group will receive surfactant by MIST technique. A 5 Fr polyurethane catheter was used for these infants. Direct laryngoscopy or video laryngoscopy was used if needed, according to the doctor's opinion. The required depth for babies with a weight ≥ 1 kg was calculated using the baby's weight (kg) plus 6. The required depth for babies < 1 kg was considered between 5.5 and 6 cm. During the intervention, sedatives and painkillers were not prescribed. Infants were under CPAP during the intervention. The dosage of surfactant in this method was 100 mg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Mehrdad Rezaei
Street address
Zand street, Nemazee Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
md_rezaie@yahoo.co.uk
2
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mehrdad Rezaei
Street address
Chamran Blvd, Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
md_rezaie@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
7th floor, Shiraz University of Medical Sciences,Zand street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5417
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Rezaei
Position
Assistant professor of Shiraz university of medical sciences
Latest degree
Subspecialist
Other areas of specialty/work
Neonatal and Pediatrics
Street address
Zand street, Nemazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
md_rezaie@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Rezaei
Position
Assistant professor of Shiraz University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Neonatal and pediatrics
Street address
Zand street, Nemazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
md_rezaie@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Rezaei
Position
Assistant professor of Shiraz University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Neonatal and pediatrics
Street address
Zand street, Nemazee hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4298
Email
md_rezaie@yahoo.co.uk
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