Comparison of Ventilators Work of Breath Based on Constant flow nasal CPAP through Pressure Limited and Electronic Feedback Pressure Control Mechanisms in the Treatment of Respiratory Distress Syndrome in Neonates Weighing 1000 grams
The present study aims at improving the quality of respiratory support in neonates with RDS.
Design
Clinical trial with randomized intervention and control groups, 70 neonates (35 participants in each group)
Settings and conduct
The present study was conducted in Alzahra Hospital in Isfahan, Iran using servo-i and Christina ventilators.
Participants/Inclusion and exclusion criteria
The inclusion criterion was neonates weighing 1000 grams with respiratory distress syndrome (Tachypnea, Intercostal retraction, nasal flaring, granting, needing inspired oxygen fraction higher than 21%) and the exclusion criteria were congenital anomaly and perinatal asphyxia (5-minute apgar score between 0 and 3, umbilical cord ph less than 7 and umbilical cord bicarbonate less than 12 mEq/Lit).
Intervention groups
Neonates in the PC-nCPAP group (intervention group) experienced respiratory support using servo-i ventilator.
Neonates in the PL-nCPAP group (control group) experienced respiratory support using Christina ventilator.
Main outcome variables
1- Work of Breath of Ventilator
2- Duration of Non-invasive ventilation
3- Rapid Shallow Breathing (RSB) index
4- Chronic Lung Disease (CLD)
5- Intra-Ventricular Hemorrhage
6- Pneumothorax
7- Surfactant Administration
8- Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120728010430N8
Registration date:2019-05-12, 1398/02/22
Registration timing:retrospective
Last update:2019-05-12, 1398/02/22
Update count:0
Registration date
2019-05-12, 1398/02/22
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
2015-08-01, 1394/05/10
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2015-08-01, 1394/05/10
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
2018-02-01, 1396/11/12
Scientific title
Comparison of Ventilators Work of Breath Based on Constant flow nasal CPAP through Pressure Limited and Electronic Feedback Pressure Control Mechanisms in the Treatment of Respiratory Distress Syndrome in Neonates Weighing 1000 grams
congenital anomaly and perinatal asphyxia (5-minute apgar score between 0 and 3, umbilical cord ph less than 7 and umbilical cord bicarbonate less than 12 mEq/Lit)
Age
From 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
neonates weighing 1000 grams with respiratory distress syndrome admission in NICU in Alzahra Hospital and Shahid Beheshti Hospital associated with Isfahan University of Medical Sciences from August, 2015 to February, 2018
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates whose first file number digit was an even number were put in PC-nCPAP group and those with an odd first file number digit were grouped as PL-nCPAP.
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 University of Medical Sciences of Isfahan
Street address
Hezar Jarib St., Azadi Sq., Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.MUI.REC.1395.3.075
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
The average Work of Breath in PC- nCPAP and PL- nCPAP
Timepoint
Every 6 hours
Method of measurement
expiratory tidal volume multiplied by dynamic pressure
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Neonates in PL-nCPAP group were supported with nCPAP respiratory support using Nasal prong Argyle (Covidien, Mansfield, USA) with the aid of Christina ventilator (Stephan, Medizintechnik, Hamburg, Germany). The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support.
Category
Treatment - Devices
2
Description
Intervention group: Neonates in PC-nCPAP group were provided with nCPAP respiratory support including Nasal prong Argyle (Covidien, Mansfield, USA) and Servo-i ventilator (Maquet, Solna, Sweden). Servo-I was equipped with a non-invasive ventilation software program and the users selected ‘Non-Invasive Ventilation’ and ‘nCPAP’ prior to activating ventilation. The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Alireza Sadeghnia
Street address
Alzahra Hospital, Isfahan University of Medical Sciences, Hezar Jarib St., Azadi Sq., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
info@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadeghnia
Street address
Alzahra Hospital, Isfahan University of Medical Sciences, Hezar Jarib St., Azadi Sq., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
info@mui.ac.ir
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
No. 5, Alley 56, Forooghi St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8137978811
Phone
+98 31 3335 1777
Email
asadeghnia@gmail.com
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
No. 5, Alley 56, Forooghi St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8137978811
Phone
+98 31 3335 1777
Email
asadeghnia@gmail.com
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
No. 5, Alley 56, Forooghi St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8137978811
Phone
+98 31 3335 1777
Email
asadeghnia@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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Calculation method for primary and secondary objectives
When the data will become available and for how long
April, 2019 to April 2020
To whom data/document is available
Medical researchers in the field of neonatology
Under which criteria data/document could be used
No limitations exist on data analysis.
From where data/document is obtainable
E-mailing the corresponding author
What processes are involved for a request to access data/document