Efficacy of nasal high frequency oscillatory ventilation versus nasal continuous positive airway pressure and double positive airway pressure in neonates less than 34 weeks with respiratory distress syndrome: a randomized controlled trial.
Comparison between 3 non invasive method include NHFOV, CPAP and DUOPAP in treatment of neonates less than 34 weeks, birth weight 1000- 2000 gr with respiratory disress syndrome(RDS) admitted in ahwaz emam khomeini hospital.
Design
Randomised, blined, parallel group trial with 192 patients.
Randomisation with sealedenvelope website.
Settings and conduct
First select six senary blocks and then numbers of one to six are assigned. The statistician randomly selects a number between one to six , And based on the obtained sequence patients are randomly placed in one of groups a, b, c. And the above sequence continues until the patient reaches the number 64 in each group. Patient (neonate) and care giver in NICU are blind and have no idea about study. Then each neonate get one of 3 treatment, randomaisly.
Participants/Inclusion and exclusion criteria
Premature neonates less than 34 gestational age، birth weight 1000 - 2000 gr with RDS admitted in ahwaz emam khomeini hospital (in 6 first hours of life) enter in study.
Great anomaly, airway anomaly, cardiovascular instability, sever asphyxia and parents dissatisfaction are exclusion factors.
Intervention groups
3 non invasive respiratory support nasal high frequency oscillatory ventilation( NHFOV) versus nasal continuous positive airway pressure( NCPAP) and double positive airway pressure ( DUOPAP) in neonates
Main outcome variables
Failure in NIV and intubation duration 48 hr after start NIV
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060854N1
Registration date:2024-02-21, 1402/12/02
Registration timing:registered_while_recruiting
Last update:2024-02-21, 1402/12/02
Update count:0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Misagh Najarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3551 5239
Email address
misagh.70.mn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-18, 1402/11/29
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of nasal high frequency oscillatory ventilation versus nasal continuous positive airway pressure and double positive airway pressure in neonates less than 34 weeks with respiratory distress syndrome: a randomized controlled trial.
Public title
Efficacy of nasal high frequency oscillatory ventilation versus nasal continuous positive airway pressure and double positive airway pressure in neonates less than 34 weeks with respiratory distress syndrome: a randomized controlled trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonates less than 34 gestational age
Birth weight 1000 - 2000 gr
Admitted in ahwaz emam khomeini hospital
In 6 first hours of life
Exclusion criteria:
Great anomaly
Airway anomaly
Cardiovascular instability
Sever asphyxia
Parents dissatisfaction
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
First select six senary blocks and then numbers of one to six are assigned. The statistician randomly selects a number between one to six , And based on the obtained sequence patients are randomly placed in one of groups a, b, c. And the above sequence continues until the patient reaches the number 64 in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are neonats.
Clinical observers do routine care and have no idea about members and study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz jondishapour university of medical science ethic committee
Street address
No. 96, west 17 Ave., padadshahr Blvd.
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Approval date
2024-02-18, 1402/11/29
Ethics committee reference number
330102012
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Failure in NIV and intubation duration 48 hr after start NIV
Timepoint
The neonate is non-invasively monitored under the supervision of a clinical caregiver at all hours of the day and if intubation is needed based on the protocol defined in the implementation of the reearch, the neonate is intubated and recorded in the neonate information collection questionnaire.
Method of measurement
With examination and chest x- ray
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: treatment with NHFOV / Second intervention group: treatment with CPAP / Third intervention group: treatment with DUOPAP
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital
Full name of responsible person
Arash malekian
Street address
No. 96 , west 17 Ave., padadshahr Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Phone
+98 61 3551 5239
Email
Misagh.70.mn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Meisam moezi
Street address
No. 96, West 17 Ave., Padadshahr
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Phone
+98 61 3551 5239
Email
Misagh.70.mn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Arash malekian
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 96, West 17 Ave., Padadshahr
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Phone
+98 61 3551 5239
Email
Misagh.70.mn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash malekian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 96, West 17 Ave., Padadshahr
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Phone
+98 61 3551 5239
Email
Misagh.70.mn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash malekian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 96, West 17 Ave., Padadshahr
City
Ahwaz
Province
Khouzestan
Postal code
6183967541
Phone
+98 61 3551 5239
Email
Misagh.70.mn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Personal data of participants can be shared after unidentifiable
When the data will become available and for how long
The access period starts 6 month after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use for systematic review articles
Journal reviewer's request to review the information
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document