Comparison of the effect of Nasal high frequency oscillatory ventilation(nHFO) with Nasal synchronized intermittent positive airway pressure(SiPAP) in the treatment of preterm infants with respiratory distress syndrome weighing less than 1500 g
Design
The clinical trial, with parallel groups, non randomized, single-center trial, sample size 60 people.
Settings and conduct
Amir Al-Momenin Hospital.
Patients will be treated with either SiPAP or nHFO according to the protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infants with a diagnosis of respiratory distress syndrome; Weight less than 1500 g; No prenatal asphyxia.
Exclusion criteria: Patients with congenital anomalies.
Intervention groups
Intervention group 1: In the nHFO group, according to the protocol, infants with Bi nasal prong and CNO device (Medin company) are subjected to non-invasive mechanical ventilation by oscillation and periodic opening and closing of the air outlet valve.
Intervention group 2: In the SiPAP group, according to the protocol, the IFD (Viasys Healthcare) injector is installed with a prong suitable for the baby and is subjected to this intervention using the SiPAP (Viasys Healthcare) support system. The Graseby capsule is placed between the umbilicus and the xiphoid appendage.
Main outcome variables
Oxygen receive the time, Duration of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N65
Registration date:2021-05-05, 1400/02/15
Registration timing:registered_while_recruiting
Last update:2021-05-05, 1400/02/15
Update count:0
Registration date
2021-05-05, 1400/02/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nHFO with SiPAP in the treatment of preterm infants with respiratory distress syndrome weighing less than 1500 g
Public title
Comparison of the effect of Nasal high frequency oscillatory ventilation(nHFO) with Nasal synchronized intermittent positive airway pressure(SiPAP) in the treatment of preterm infants with respiratory distress syndrome weighing less than 1500 g
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with a diagnosis of respiratory distress syndrome
Weight less than 1500 g
No prenatal asphyxia
Exclusion criteria:
Patients with congenital anomalies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.SEMUMS.REC.1399.338
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
Oxygen receive time
Timepoint
Before the intervention and 1 week after the intervention
Method of measurement
Clinical examination (Number of days of receiving oxygen)
2
Description
Duration of treatment
Timepoint
Before the intervention and 1 week after the intervention
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the nHFO group, according to the protocol, infants with Bi nasal prong and CNO device (Medin company) are subjected to non-invasive mechanical ventilation by oscillation and periodic opening and closing of the air outlet valve.
Category
Treatment - Devices
2
Description
Intervention group 2: In the SiPAP group, according to the protocol, the IFD (Viasys Healthcare) injector is installed with a prong suitable for the baby and is subjected to this intervention using the SiPAP (Viasys Healthcare) support system. The Graseby capsule is placed between the umbilicus and the xiphoid appendage.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Navid Danaei
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
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
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
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
Semnan University of Medical Sciences
Full name of responsible person
Navid Danaie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infants
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Navid Danaie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infants
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyedeh Niloufar Amir Khalili
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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