Nasal continuous positive airway pressure (NCPAP) versus Humidified high flow nasal cannula (HHFNC) in treatment of premature infants with respiratory distress
Overall Objective:
In this study, the-therapeutic effect of Nasal high frequency ventilation(HHFNC) versus nasal continuous positive airway pressure(NCPAP) for treatment of respiratory distress syndrome has been compared
Design
In this randomized control trial study 54 premature infants with respiratory distress syndrome after surfactant therapy were randomly as every other one recruited in to two groups(HHFNC vs NCPAP) and their outcomes were compared.In NCPAP group we used peep=4-6 and flow=8 lit/min and in HHFNC group we used flow=4-7 lit/min
Settings and conduct
In this study premature infants with respiratory distress syndrome whom were admitted to Shohada Hospital and Mahdieh Hospital after surfactant therapy were randomly recruited in to two groups(HHFNC vs NCPAP) and their outcomes were compared.
HHFNC GROUP :In this group, using an oxygen blender, treatment is given by giving oxygen at a suitable and moist concentration and with a flow of 4 to 7 liters per minute through the nasal cannula.
NCPAP GROUP:In this group, the treatment is done by using the CPAP mode from the ventilator device and by adjusting the flow of 8 liter per minute and PEEP 5 to 7 and the appropriate concentration of oxygen through the nasal cannula.
Main outcome variables
the length of hospital stay
the length of oxygen delivery
nasal trauma
bronchopulmonary displasia
death
General information
Reason for update
Acronym
Nasal continuous positive pressure(NCPAP)
IRCT registration information
IRCT registration number:IRCT20151122025184N2
Registration date:2021-07-29, 1400/05/07
Registration timing:retrospective
Last update:2021-07-29, 1400/05/07
Update count:0
Registration date
2021-07-29, 1400/05/07
Registrant information
Name
Roya Taheri Tafti
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 8037
Email address
royataheritafti@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Nasal continuous positive airway pressure (NCPAP) versus Humidified high flow nasal cannula (HHFNC) in treatment of premature infants with respiratory distress
Public title
:NCPAP versus HHFNC in treatment of premature infants with respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
premature infants with GA fewer than 37 weeks
premature infants with respiratory distress syndrome
premature infants with respiratory distress syndrome who can extubate after surfactant therapy
Organizational Committee of Ethics in Biomedical Research, Vice Chancellor for Research, Shahid Behe
Street address
tajrish square
City
tehran
Province
Tehran
Postal code
1989934148
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.135
Health conditions studied
1
Description of health condition studied
respiratory distress syndrome in premature infants
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
the extubation failure rate in two groups of NCPAP and HHFNC within 7 days after the intervention
Timepoint
within 7 days after INSURE(intubation and surfactant injection and extubation)
Method of measurement
EXAMINATION AND STUDY OF FILES
2
Description
the length of oxygen requirement after surfactant therapy
Timepoint
during after surfactant therapy
Method of measurement
EXAMINATION AND STUDY OF FILES
Secondary outcomes
1
Description
Pneumotorax and air leaks of the plural space due to the two type of noninvasive ventilation during the period of receiving respiratory support
Timepoint
During the period of receiving noninvasive respiratory support (intervention)
Method of measurement
EXAMINATION AND CXR AND STUDY OF FILES
2
Description
Intraventricular brain hemorrhage during the period of receiving respiratory support
Timepoint
During the period of receiving noninvasive respiratory support (the intervention)
Method of measurement
examination and brain sonography
3
Description
hospital length of stay
Timepoint
The total length of hospitalization of the studied neonates
Method of measurement
study of files
4
Description
nasal trauma includes ulceration and necrosis during the period of receiving respiratory support
Timepoint
During the period of receiving respiratory support(the intervention)
Method of measurement
inspection
Intervention groups
1
Description
Intervention group: HHFNC GROUP:In this group, using an oxygen blender, treatment is given by giving oxygen at a suitable and moist concentration and with a flow of 4 to 7 liters per minute through the nasal cannula.
Category
Treatment - Devices
2
Description
Intervention group: NCPAP GROUP:In this group, the treatment is done by using the CPAP mode from the ventilator device and by adjusting the flow of 8 liter per minute and PEEP 5 to 7 and the appropriate concentration of oxygen through the nasal cannula.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh hospital
Full name of responsible person
dr roya taheritafti
Street address
shoosh street
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
shohada e tajrish hospital
Full name of responsible person
dr roya taheritafti
Street address
tajrish square
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Clinical Research Development Unit of ShohadaTajrish Hospital
Street address
tajrish square
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr_shohada@sbmu.ac.ir
Web page address
http://shmc.sbmu.ac.ir/index.jsp?pageid=6173&p=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr roya taheritafti
Position
ASISTANT PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
KOOYE NASR STREET
City
TEHRAN
Province
Tehran
Postal code
1446943853
Phone
+98 21 8828 8037
Email
royataheritafti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr roya taheritafti
Position
asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
kooye nasr
City
tehran
Province
Tehran
Postal code
1446943853
Phone
+98 21 8828 8037
Email
royataheritafti@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr roya taheritafti
Position
asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
kooye nasr
City
tehran
Province
Tehran
Postal code
1446943853
Phone
+98 21 8828 8037
Email
royataheritafti@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