Airway Pressure and HHFNC(Humidified high-flow nasal cannula) after surfactant injection in the treatment of respiratory distress in Premature neonates less than 34 weeks
The aim of present study was to Compare Effectiveness of NCPAP (Nasal Positive Airway Pressure) and HHFNC (Humidified high-flow nasal cannula) after surfactant injection in the treatment of respiratory distress in premature neonates less than 34 weeks.
Design
Randomized clinical trial
Settings and conduct
This study is a randomized clinical trial that will be conducted in the NICU section of the Ayatollah Rouhani Hospital in Babol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonate neonate with respiratory distress with surfactant indication for.
Exclusion criteria: Neonate with congenital heart disease; Neonate is fifth minute Apgar score of less than five.
Intervention groups
Intervention group 1: Ventilatory nasal continuous positive airway pressure
Intervention group 2: Ventilatory humidified high flow nasal cannula
Main outcome variables
Response to treatment
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180226038865N1
Registration date:2018-04-04, 1397/01/15
Registration timing:prospective
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Avishan Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
a.mohammadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Airway Pressure and HHFNC(Humidified high-flow nasal cannula) after surfactant injection in the treatment of respiratory distress in Premature neonates less than 34 weeks
Public title
Comparison of two forms of non-invasive respiratory supporting preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Premature neonate with respiratory distress with surfactant indication for.
Exclusion criteria:
Exclusion criteria: infants with congenital heart disease.
Exclusion criteria: is fifth minute Apgar score of less than five.
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
randomization
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
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
MUBABOL.HRI.REC.1396.36
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborns
ICD-10 code
p22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Response to treatment
Timepoint
Every 2 hours for 24 hours
Method of measurement
Comparing survival rates
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ventilatory nasal continuous positive airway pressure
Category
Treatment - Devices
2
Description
Intervention group 2: Ventilatory humidified high flow nasal cannula
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani
Full name of responsible person
Zahra Akbarian Rad
Street address
Ganjafroz Street ,Ayatollah Ruhani
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
zhr_akbarian@yahoo.com
Web page address
http://rohani.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ali Akbar Moghaddamnia
Street address
Babol University of Medical Sciences, Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4727
Fax
+98 11 3219 9591
Email
info@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian Rad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
zhr_akbarian@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian Rad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
zhr_akbarian@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian rad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
zhr_akbarian@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD