Comparison of the effectiveness of nasal continuous positive airway pressure (NCPAP) therapy with combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infants
Comparison of the effectiveness of nasal continuous positive airway pressure (NCPAP) therapy with combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infants
Design
Clinical trial with control group and two arm parallel group randomised trial with blinded
Settings and conduct
The study perform in NICU Parents of neonates were kept unaware of groups their neonate was allocate to
Participants/Inclusion and exclusion criteria
infants less than 35 weeks old with RDS were enrolled.Death rate of infants during the study, chromosomal anomalies, associated severe anomalies, pulmonary disease other than RDS, congenital heart disease, IVH Grade 2 and abovewere the exclusion criteria
Intervention groups
Control group manage with nasal continuous positive airway pressure (NCPAP) and another group manage with combination of High-Frequency Oscillations and NCPAP
Main outcome variables
Hospital stay
Oxygenation duration time
Pneumothorax rate
Pulmonary Hemorrhage rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180915041040N3
Registration date:2019-08-17, 1398/05/26
Registration timing:retrospective
Last update:2019-08-17, 1398/05/26
Update count:0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Roya Choopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
choopani.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
2018-05-20, 1397/02/30
Scientific title
Comparison of the effectiveness of nasal continuous positive airway pressure (NCPAP) therapy with combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infants
Public title
Comparison of the effectiveness of nasal continuous positive airway pressure (NCPAP) therapy with combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infants less than 35 weeks old with RDS
Exclusion criteria:
Death of neonate
Chromosomal anomaly
Congenital heart defect
, IVH Grade 2 and above
severe anomalies
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The infants were randomly assigned to two groups using a computerized random number table as NCPAP group and NCPAP+NHFVO group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind
Parents of neonates were kept unaware of groups their neonate was allocate to
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Parastar Street
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874119
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
IR.SKUMS.REC.1395.291
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Time of haspitalization
Timepoint
Discharge time
Method of measurement
Number day
Secondary outcomes
empty
Intervention groups
1
Description
Control group:Nasal continuous positive airway pressure (NCPAP) therapy in neonates with RDS
Category
Treatment - Devices
2
Description
Intervention group:combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infants
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Roya Choupani
Street address
Parastar Street
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
886854633
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
choopani.r@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Kamal Solati
Street address
Kashani Street
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahr-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choupani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choupani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
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
There are no information
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
No - There is not 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