A comparative study of the response to Heated and Humidified High Flow Nasal Cannula treatment with Continuous Positive Airway Pressure method in premature infants with respiratory distress syndrome admitted to Qom Khairin Salamat Hospital
Comparison of the therapeutic response of Heated and Humidified High Flow Nasal Cannula (HHHFNC) with Continuous Positive Airway Pressure (CPAP) in premature infants admitted to Khairin Salamat Hospital, Qom
Design
An unblinded clinical trial with two randomized parallel groups using the permutation block method with 60 neonate sample
Settings and conduct
Randomly, neonate born in Khairin Salamat Qom hospital who have evidence of respiratory distress syndrome will be randomly divided into two groups, and one group will receive Heated and Humidified High Flow Nasal Canula and the other group will receive Continuous Positive Airway Pressure.
Participants/Inclusion and exclusion criteria
Evidence of respiratory distress syndrome in simple chest X-Ray, aged more than 28 weeks and less than 32 weeks, RDS Score at birth 4, 5, and 6, no surfactant reception
Intervention groups
Thirty infants in one group will receive warm and Humid High Flow Nasal Cannula, and another thirty infants will be ventilated with Continuous Positive Airway Pressure.
Main outcome variables
Improvement of respiratory distress syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231001059581N1
Registration date:2023-10-19, 1402/07/27
Registration timing:prospective
Last update:2023-10-19, 1402/07/27
Update count:0
Registration date
2023-10-19, 1402/07/27
Registrant information
Name
Alireza Saadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3162 5100
Email address
asaadati@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the response to Heated and Humidified High Flow Nasal Cannula treatment with Continuous Positive Airway Pressure method in premature infants with respiratory distress syndrome admitted to Qom Khairin Salamat Hospital
Public title
A comparative study of the response to Heated and Humidified High Flow Nasal Cannula treatment with Continuous Positive Airway Pressure method in premature infants with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
RDS 4-6
Clinical sign Of RDS
Gestational Age Between 28 To 32
Weight Less Than 1500g
Exclusion criteria:
Major Congenital Anomaly
Asphyxia Sign
Cyanotic Heart Disease
Emergency Intubation
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize people in two groups, permuted block randomization method of 4 is used. Considering two groups A and B, the randomization process will be as follows. The entire randomization file is available as an Excel file (randomization was done with SAS software version 9)
Seed: 64404995453716
Block sizes: 4
Actual list length: 60
block identifier, block size, sequence within block, treatment
• 1, 4, 1, Group B
In this method, group A will receive HHHFNC treatment and group B will receive CPAP treatment. For example, the first neonate born will be placed in block number one, and according to the block sequence, it will sit in position number one, and according to the random data of the software will receive treatment B
The first number is the block number, the second number is the block size and the third number is the block sequence
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
From the beginning of the study, Every 4 hours until treatment or failure
Method of measurement
Downs scale Score
Secondary outcomes
1
Description
Need for intubation
Timepoint
Every 4 hours based on RDS score until treatment or failure
Method of measurement
Clinical examination, RDS score
2
Description
Treatment duration
Timepoint
Every 4 hours based on RDS score until treatment or failure
Method of measurement
Day
Intervention groups
1
Description
First Intervention group: Neonate In The First Group Receive Oxygen With A Continuous Pressure Of 5 To 6 Cm Of Water And A Flow Rate Of 8 To 10 By CPAP.
Category
Treatment - Devices
2
Description
The Second Intervention group: In This Group, Neonate Receive Air With A Temperature Of 37 Degrees And Humidified With An Average Volume Of 2750 cc Per Minute (Neonate Weighing Less Than 1000 Grams Will Receive 2500 cc Of Air Per Minute And Neonate Weighing More Than 1000 Grams Will Receive 3000 cc Of Air Per Minute).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Khaerin Salamat Hospital
Full name of responsible person
Alireza Saadati
Street address
Qom, Delazar St
City
Qom
Province
Ghoum
Postal code
3715873355
Phone
+98 25 3133 3000
Email
Nekoeihospital@muq.ac.ir
2
Recruitment center
Name of recruitment center
Fatemeh Masoumeh Hospital
Full name of responsible person
Alireza Saadati
Street address
Imam Khomeini St
City
Qom
Province
Ghoum
Postal code
3719815539
Phone
+98 25 3665 1801
Email
Hospital-masumeh@muq.ac.ir
3
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Alireza Saadati
Street address
North Hekmat, Tohid Blvd
City
Qom
Province
Ghoum
Postal code
3717994544
Phone
+98 25 3110 0000
Email
shohada@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Rahim Aali
Street address
Shahid Lavasani (Saheli) St., Qom, I.R. Iran
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 4011
Email
int_office@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Saadati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam KhomeniSt ,Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5100
Fax
Email
asaadati@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Saadati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam KhomeniSt ,Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5100
Fax
Email
asaadati@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Saadati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam KhomeniSt ,Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5100
Fax
Email
asaadati@muq.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