The Efficacy of Noninvasive Cycled-PAP in the Management of Respiratory Distress Syndrome in Infants with a Gestational Age of 28 to 32 Weeks: NIPPV Vs. Synchronized-NIPPV; A Clinical Trial
The presents study aims at assessing the effectiveness of Non-Invasive Ventilation (NIV) in managing Respiratory Distress Syndrome (RDS).
Design
Randomized clinical trial, not blinded, with 70 participants
Settings and conduct
The study will be conducted in Neonatal Intensive Care Unit (NICU) wards of Beheshti Hospital and Alzahra Hospital in Isfahan on neonates aged 28-32 weeks involved in Respiratory Distress Syndrome (RDS) after surfactant administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Neonates with 28-32 weeks of gestation suffering from Respiratory Distress Syndrome (RDS)
Exclusion criteria:
1- Potential abnormal chromosome count
2- Developmental malformation
3- Birth asphyxia
Intervention groups
Control group will undergo support from two levels of pressure without synchronization.
The intervention group will undergo support from two levels of pressure with synchronization.
Main outcome variables
Avoiding mechanical invasive ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120728010430N12
Registration date:2025-01-26, 1403/11/07
Registration timing:retrospective
Last update:2025-01-26, 1403/11/07
Update count:0
Registration date
2025-01-26, 1403/11/07
Registrant information
Name
Alireza Sadeghnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 1777
Email address
sadeghnia@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Noninvasive Cycled-PAP in the Management of Respiratory Distress Syndrome in Infants with a Gestational Age of 28 to 32 Weeks: NIPPV Vs. Synchronized-NIPPV; A Clinical Trial
Public title
Investigation of Noninvasive Cycled-PAP Efficacy in RDS Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with the gestational age of 28 to 32 weeks with regards to their clinical conditions and radiologic RDS being managed using nCPAP withing 2 hours after birth receiving surfactant through INSURE process
Filling out the written consent forms
Exclusion criteria:
Evidence of chromosomal or genetic abnormalities
significant congenital anomalies or malformations
Any type of counter-indication causing limitations in implementing NIV (such as the need for surgical interventions in the digestive system)
Evidence of perinatal asphyxia
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Infants with a gestational age of 28 to 32 weeks who meet the inclusion criteria will be randomly allocated into one of two groups: SNIPPV or NIPPV. Randomization will be performed using a block randomization method with equal block sizes. First, the total sample size is estimated, and the block size (e.g., blocks of 4 or 6) is determined. Then, a list of group allocations (different combinations of intervention and control groups within each block) is generated in advance using random number generation software such as Random Allocation Software.
When an infant enters the study, their allocation to either the intervention or control group is determined sequentially based on the pre-prepared randomization list. The individual responsible for group assignment uses this allocation list and has no involvement in the treatment process to ensure blinding and prevent bias. This approach guarantees that randomization is both random and balanced across the groups, with the block randomization process strictly adhered to.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.MUI.MED.REC.1402.173
Health conditions studied
1
Description of health condition studied
Shortage of surfactant causes RDS.
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Need for mechanical ventilation 72 hours after birth in preterm neonates suffering from RDS comparing SNIPPV and NIPPV administration
Timepoint
The period including 72 hours after birth
Method of measurement
Investigating arterial blood gases
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For infants in the SNIPPV group, non-invasive ventilation parameters, including IPAP=dynamic pressure، EPAP=5 cm H2O، Ti=0.25”، pressure trigger=20%(dynamic pressure) will be defined for the ventilator in AC respiratory mode; In cases when an infant's need for inspiratory oxygen fraction remains higher than 40% to maintain oxygen saturation in an acceptable range, Beractant will be re-administered 6 hours after the previous surfactant dose, up to a maximum of four doses in the therapeutic course. Capillary blood gas (CBG) measurements will be performed before and after administering each surfactant dose and every 12 hours thereafter. Adjustments in respiratory management will be made based on CBG results. For infants whose oxygen saturation level, despite surfactant administration, still does not fall within the acceptable range, EPAP will be initially increased by 1-2 cmH2O and then FiO2 will be increased by 5-10% as needed. The weaning process includes reducing EPAP and then FiO2, with the infant being separated from respiratory support at EPAP=4 cmH2O and FiO2≤25%. If any of the following occurred, NIV was discontinued, followed by intubation and invasive mechanical ventilation: inability to establish acceptable ventilation and respiratory failure (pH<7.2 & PCO2>65 mmHg), more than three apnea episodes per hour requiring stimulation or ventilation with bag and mask, and FiO2>75% requirement to maintain oxygen saturation within the 90-95% range.
Category
Treatment - Devices
2
Description
For infants in the NIPPV group, the EasyFlow prongs will be attached; and non-invasive ventilation parameters, including IPAP=dynamic pressure, EPAP=5 cm H2O, Ti=0.45", and rate=25 bpm will be defined for the ventilator in IMV respiratory mode; In cases when an infant's need for inspiratory oxygen fraction remains higher than 40% to maintain oxygen saturation in an acceptable range, Beractant will be re-administered 6 hours after the previous surfactant dose, up to a maximum of four doses in the therapeutic course. Capillary blood gas (CBG) measurements will be performed before and after administering each surfactant dose and every 12 hours thereafter. Adjustments in respiratory management will be made based on CBG results. For infants whose oxygen saturation level, despite surfactant administration, still does not fall within the acceptable range, EPAP will be initially increased by 1-2 cmH2O and then FiO2 will be increased by 5-10% as needed. The weaning process includes reducing EPAP and then FiO2, with the infant being separated from respiratory support at EPAP=4 cmH2O and FiO2≤25%. If any of the following occurred, NIV was discontinued, followed by intubation and invasive mechanical ventilation: inability to establish acceptable ventilation and respiratory failure (pH<7.2 & PCO2>65 mmHg), more than three apnea episodes per hour requiring stimulation or ventilation with bag and mask, and FiO2>75% requirement to maintain oxygen saturation within the 90-95% range.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Alireza Sadeghnia
Street address
Beheshti Obstetrics and Gynecology Hospital - Motahari St., Felezi bridge
City
Isfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
asadeghnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Fallah
Street address
Faculty of Medicine, Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
asadeghnia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghnia
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Isfahan university of medical sciencies, hezar jarib Avn.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3335 1777
Fax
Email
sadeghnia@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghnia
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Isfahan university of medical sciencies, hezar jarib Avn.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3335 1777
Fax
Email
sadeghnia@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghnia
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Isfahan university of medical sciencies, hezar jarib Avn.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3335 1777
Fax
Email
sadeghnia@med.mui.ac.ir
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Relevant data will be shared on demand.
When the data will become available and for how long
Relevant data will be shared for 1 year after publication.
To whom data/document is available
Data will be shared with researchers in this area.
Under which criteria data/document could be used
Data will be shared for medical purposes only.
From where data/document is obtainable
The corresponding author must be contacted via e-mail.
What processes are involved for a request to access data/document
Sending and e-mail to the corresponding author shall suffice.