A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants
A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants
Design
Clinical trial including two-arm parallel-group, randomized, with 20 patients, single blinded
Settings and conduct
This study was performed on preterm patients under 35 weeks in the neonatal intensive care unit of Amir Al-Momenin Hospital in Semnan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age between 25 to 35 weeks; Moderate to severe respiratory distress syndrome.
Exclusion criteria: Patients with congenital anomalies; Patients needed endotracheal intubation.
Intervention groups
First intervention group: Nasal Continuous Positive Airway Pressure group; These infants underwent non-invasive ventilation Continuous Positive Airway Pressure using Bi nasal prong, Bubble Continuous Positive Airway Pressure, hot and humid airflow, and blender. Continuous Positive Airway Pressure was started with 5 cmH2O to keep the Saturation between 90 to 94 percent.
Second Intervention group: Nasal high-frequency oscillation group, These infants underwent non-invasive mechanical ventilation using CNO devices for Medin company and Bi nasal prong and using oscillation and periodic opening and closing of the air outlet valve. Ventilation started by using CPAP with 5 cmH2O, frequency of 10 Hz, and oscillation that started with 5. At the eginning of ventilation, visible vibration of the upper chest was noted. It was started to keep the Saturation between 90 to 94 percent.
Main outcome variables
O2 therapy and O2 therapy time; MV (mechanical ventilation) and its duration and age of infants while MV; Apnea and age of infants at that time; surfactant and age of infants while that time; Pneumothorax and age of infants at that time;
A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants
Public title
A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 25 to 35 weeks
Moderate to severe respiratory distress syndrome
Exclusion criteria:
Patients with congenital anomalies
Patients needed endotracheal intubation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 10 members using block randomization with block sizes of 2.
Randomized permutation blocks (block 2).
Excel software rand function was used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are infants and it will be impossible for them to explain the method, treatment groups, and how to randomize; Therefore, participants will not be aware of the type of intervention received and are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- Shahrood Branch
Determining premature infants at the beginning of the study
Method of measurement
By measuring gestational age between 25 to 35 weeks
2
Description
respiratory distress
Timepoint
At the beginning of the study
Method of measurement
Using medical examinations
Secondary outcomes
1
Description
O2 Therapy
Timepoint
at any time interval of study If it's needed
Method of measurement
Using medical examinations
2
Description
O2 Therapy time
Timepoint
While O2 Therapy
Method of measurement
Counting the days of oxygen therapy
3
Description
invasive mechanical ventilation
Timepoint
at any time interval of study If it's needed
Method of measurement
If the infant does not respond to non-invasive mechanical ventilation
4
Description
Duration of using mechanical ventilation
Timepoint
While using mechanical ventilation
Method of measurement
Counting the days of using mechanical ventilation and Using the data collection form
5
Description
The infant's age at the time of use of mechanical ventilation
Timepoint
While using mechanical ventilation
Method of measurement
Age is calculated based on hours and Using the data collection form
6
Description
Apnea
Timepoint
At any time of apnea During or after being placed under the studied devices
Method of measurement
By observing the infant's breathing measuring devices
7
Description
The infant's age at the time of apnea
Timepoint
At any time of apnea
Method of measurement
Age is calculated based on hours and Using the data collection form
8
Description
surfactant
Timepoint
At any time of study if necessary
Method of measurement
Based on the physician's opinion and when there is no progress in the infant's respiratory recovery
9
Description
Age of infants at surfactant indication
Timepoint
At the time of surfactant indication
Method of measurement
Age is calculated based on hours and Using the data collection form
10
Description
Pneumothorax
Timepoint
During or after being placed under the studied devices
Method of measurement
By imaging and examination
11
Description
Age of infant's at the pneumothorax incidence
Timepoint
At the time of pneumothorax incidence
Method of measurement
Age is calculated based on hours and Using the data collection form
12
Description
IVH (Intra ventricular hemorrhage)
Timepoint
During or after being placed under the studied devices
Method of measurement
imaging
13
Description
Age of infant's at intraventricular hemorrhage
Timepoint
At the time of intraventricular hemorrhage
Method of measurement
Age is calculated based on hours and Using the data collection form
14
Description
CLD (Chronic Lung Disease)
Timepoint
after being placed under the studied devices
Method of measurement
imaging and examination
Intervention groups
1
Description
First intervention group: Nasal Continuous Positive Airway Pressure group; These infants underwent non-invasive ventilation Continuous Positive Airway Pressure using Bi nasal prong, Bubble Continuous Positive Airway Pressure, hot and humid airflow, and blender. Continuous Positive Airway Pressure was started with 5 cmH2O to keep the Saturation between 90 to 94 percent.
Category
Treatment - Devices
2
Description
Second Intervention group: Nasal high-frequency oscillation group, These infants underwent non-invasive mechanical ventilation using CNO devices for Medin company and Bi nasal prong and using oscillation and periodic opening and closing of the air outlet valve. Ventilation started by using CPAP with 5 cmH2O, frequency of 10 Hz, and oscillation that started with 5. At the beginning of ventilation, visible vibration of the upper chest was noted. It was started to keep the Saturation between 90 to 94 percent.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir AI_Momenin hospital
Full name of responsible person
Dr. Navid Danai
Street address
Amir Al_Momenin hospital, Mostafa Khomeini Blvd, Madar Square
City
Semnan
Province
Semnan
Postal code
35197-34731
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
info@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Islamic Azad University
Full name of responsible person
Maryam Jandaghi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 265, Bagh Ferdos Ave, Shahid Ghods Ave, Amitis Apartment
City
Semnan
Province
Semnan
Postal code
3514618563
Phone
+98 23 3332 3194
Fax
Email
M.Jandaghi73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Jandaghi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 265, Bagh Ferdos Ave, Shahid Ghods Ave, Amitis Apartment
City
Semnan
Province
Semnan
Postal code
3514618563
Phone
+98 23 3332 3194
Fax
Email
M.Jandaghi73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Jandaghi
Position
Medical intern
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
No 265, Bagh Ferdos Ave, Shahid Ghods Ave, Amitis Apartment
City
Semnan
Province
Semnan
Postal code
3514618563
Phone
+98 23 3332 3194
Fax
Email
M.Jandaghi73@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