Comparison of the consequences of using two methods of "continuous positive airway pressure" and "high frequency oscillation" in the treatment of respiratory distress in premature neonates
Determining the consequences of using two methods of "continuous positive airway pressure" and "high frequency oscillation" in the treatment of respiratory distress in premature neonates
Design
Clinical trial without control group will start with two parallel groups without blinding and randomized on 78 patients. The allocation of samples in each group will do by blocked randomization
Settings and conduct
Infants are randomly treated with either "continuous positive airway pressure" or "high frequency oscillation" for a maximum of 2-3 days. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. In both methods, nasal single pronge (3-4 cm inside the nose) is used. During both procedures, if the baby needs surfactant based on clinical signs and chest radiograph, the insure method will be performed and after extubation, the baby will be put back on the previous settings.
Participants/Inclusion and exclusion criteria
All premature infants (gestational age 28-24 weeks)
Birth weight less than 2000 grams
Hospitalization in neonatal intensive care unit due to respiratory distress
Intervention groups
Infants randomly treated with either "high frequency oscillation" or "continuous positive airway pressure" for a maximum of 2-3 days. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. In both methods, nasal single pronge (3-4 cm inside the nose) is used. During both procedures, if the baby needs surfactant based on clinical signs and chest X-Ray, the insure method will be performed and after extubation, the baby will be put back on the previous settings, In addition, the control group is not considered.
Main outcome variables
- Initial outcome:
The baby needs to be intubated
Success or failure of any method
- Secondary consequence:
Pulmonary or extrapulmonary complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190416043290N2
Registration date:2020-12-17, 1399/09/27
Registration timing:registered_while_recruiting
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Raheleh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 1316
Email address
raheleh.moradi1987@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the consequences of using two methods of "continuous positive airway pressure" and "high frequency oscillation" in the treatment of respiratory distress in premature neonates
Public title
Comparison of two methods of respiratory support in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All premature neonates (gestational age of 28-34 weeks)
Neonates with birth weight less than 2000 gr.
Hospitalization in the neonatal intensive care unit due to respiratory distress during the first 24 hours after birth
Exclusion criteria:
Severe asphyxia (apgar of minutes 5 less than or equal to 6)
Positive blood culture upon arrival at the neonatal intensive care unit
Congenital malformations (whether pulmonary or extrapulmonary)
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into 2 groups by Blocked Randomization method; Thus, the blocks will be 4 and, considering that the sample size is generally 78 people, 20 blocks of 4 will be considered.
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
Medical Ethics Committee of Tehran University of Medical Sciences
Street address
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.239
Health conditions studied
1
Description of health condition studied
respiratory distress of neonates
ICD-10 code
P22
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
Success or failure of any method
Timepoint
Maximum 3 days
Method of measurement
Need for endotracheal intubation or pulmonary or extrapulmonary complications
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "continuous positive airway pressure " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Cindy" or "Ventilator" the amount of oxygen that reaches the patient in each inspiratory is regulated by 40-70% and the positive end expiratory pressure will be 4-6 centimeters of water. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used.
Category
Treatment - Devices
2
Description
Intervention group 2: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "high frequency oscillation " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Stephanie Soufie"; the open airway pressure will be set at 10 centimeters of water and the frequency of the device will be 6-8 hertz. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Dr. tahereh Esmaeilnia Shirvani
Street address
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2357
Fax
+98 21 6659 1315
Email
tesmaeilnia@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad ali sahraian
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 8163 3685
Fax
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raheleh Moradi
Position
Midwife-Researcher
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2357
Fax
+98 21 6659 1315
Email
raheleh.moradi1987@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Esmaeilnia
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 61192357
Email
tesmaeilnia@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raheleh Moradi
Position
Midwife-Researcher
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
raheleh.moradi1987@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Information on study outcomes can be shared.
When the data will become available and for how long
6 months after publication of results.
To whom data/document is available
Free and academic researchers
Under which criteria data/document could be used
Only information about the outcomes of the study is provided, which is unimpeded if the material and intellectual rights of the Maternal and Fetal Research Center are protected.
From where data/document is obtainable
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran
What processes are involved for a request to access data/document
Visit in research center or communication by email:
mfnhrc@tums.ac.ir