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Comparison of the effect of (NSIMV) Nasal Synchronized Intermittent Mandatory Ventilation whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital

Protocol summary

Study aim
Comparing effect of Nasal Synchronized Intermittent Mandatory Ventilation with Nasal high frequency oscillatory ventilation in infants who need non invasive ventilation
Design
This double-blind two phaseic clinical trial study with a parallel group, 180 premature babies needing non-invasive mechanical ventilation will be divided into two groups, Nasal high frequency oscillatory ventilation and Nasal Synchronized Intermittent Mandatory Ventilation, using a simple randomization method.
Settings and conduct
One hundred eighty infants who need non-invasive mechanical ventilation admitted to Mufid Children's Hospital, Tehran, Iran will be allocated to two groups by a simple randomization method. The duration of the intervention will be adjusted based on the needs of the infant. The therapist is responsible for the study and the infant is not involved in the allocation of the intervention group. In addition, the researcher and the data analyst are not involved in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants with a gestational age of more than 26 weeks needing respiratory support Exclusion criteria: intubation before randomization, long-term resuscitation, lack of parental consent, infants with contraindication of non-invasive mechanical ventilation, infants with head and face anomalies, grade 3 and 4 intraventricular hemorrhage.
Intervention groups
Intervention group 1: non-invasive mechanical ventilation with Nasal Synchronized Intermittent Mandatory Ventilation mode intervention group 2: non-invasive mechanical ventilation with nasal HFO mode
Main outcome variables
Duration of need for mechanical ventilation in premature infants under study

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221120056556N1
Registration date: 2023-01-24, 1401/11/04
Registration timing: prospective

Last update: 2023-01-24, 1401/11/04
Update count: 0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Minoo Fallahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
minoofallahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of (NSIMV) Nasal Synchronized Intermittent Mandatory Ventilation whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital
Public title
Comparison of the effect of (NSIMV) Nasal Synchronized Intermittent Mandatory Ventilation whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include: Premature babies hospitalized in the intensive care unit with a gestational age of more than 26 weeks who need respiratory support. Informed consents of the baby's parents
Exclusion criteria:
Babies who were intubated for resuscitation or for another reason before randomization. cardio-pulmonary arrest requiring prolonged resuscitation lack of consent of the baby's parents Transferring the baby out of the neonatal intensive care unit before randomization In infants with the contraindication of non-invasive mechanical ventilation, such as infants with esophageal atresia or diaphragmatic hernia within 10 to 14 days after surgery Babies with head and face anomalies that do not allow ventilation inside the baby's nose, such as cleft lip and palate Intraventricular hemorrhage in grade 3 and 4
Age
From 1 day old to 30 days old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 180
More than 1 sample in each individual
Number of samples in each individual: 90
The studied population, all babies with a gestational age of more than 26 weeks and less than 37 weeks will need mechanical ventilation admitted to Mofid Children's Hospital in Tehran. Also, all babies with contraindications for non-invasive mechanical ventilation, such as babies with head and face anomalies, grade 3 and 4 intracerebral hemorrhage, cardiopulmonary arrest, lack of parental consent, will be excluded from the study. The number of 180 infants with inclusion criteria will be divided into two groups, nasal high frequency oscillatory ventilation (NHFOV) and nasal synchronized intermittent mandatory ventilation (NSIMV), based on simple randomization. The initial settings in the NHFOV group were as follows: frequency of 10 Hz (subsequent regulation range, 8-12, in steps of 1 Hz); inspiratory time of 50% (1:1)19; an oscillation amplitude (delta P) of 20-35 cm H2O Fio2: 30-40% The initial settings in the NSIMV group were as follows: PIP: 14-16 cmH2O PEEP: 5-6 cmH2O Rate: 30-40 Ti: 0.4 FiO2 : 30-40% then information related to the baby's gestational age, birth weight, baby's sex, Apgar 1st minute, Apgar 5th minute, Apgar 10th minute, Antenatal corticoids, type of delivery, gestational diabetes, duration of treatment under mechanical ventilation, use of Surfactant and oxygen level before extubation, primary outcomes (re-intubation, blood carbon dioxide pressure) and secondary outcomes (Incidence of Intraventricular hemorrhage, Patent ductus arteriosus, Retinopathy of permaturity, Bronchopulmonary dysplasia, Necrotizing enterocolitis, duration of hospitalization and death in each Two groups will be collected.
Randomization (investigator's opinion)
Randomized
Randomization description
Premature babies needing non-invasive mechanical ventilation are divided into two non-invasive mechanical ventilation groups(HFO and SIMV) using simple randomization method and random number table. So that patients who met the criteria s to enter the study will be assigned a number, and then without prior knowledge, even numbers will be placed in the intervention group and odd numbers will be placed in the control group. In this way, each member of the community will have an equal chance to be selected in order to be included in both intervention and control groups, and the researcher will not interfere in the selection of samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, premature babies who need non-invasive mechanical ventilation will be divided into two groups. Due to the study method and the impossibility of blinding mechanical ventilation, the doctor and nurse caring for the baby will be informed about the selected method for non-invasive mechanical ventilation, but the statistical analyzer of the research will not be informed about the allocation of patients in two groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Scences
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.SBMU.MSP.REC.1401.186

Health conditions studied

1

Description of health condition studied
Respiratory Distress Syndrome/ Prematurity
ICD-10 code
P22
ICD-10 code description
Respiratory distress of newborn

Primary outcomes

1

Description
Duration of need for mechanical ventilation in premature infants under study
Timepoint
In the total hospitalization time of the premature baby under study in the neonatal intensive care unit
Method of measurement
The number of days without the need for mechanical ventilation in the baby

Secondary outcomes

1

Description
Patent ductus arteriosus
Timepoint
During the hospitalization of the baby
Method of measurement
Echocardiography by pediatric cardiologist

2

Description
Retinopathy of permaturity
Timepoint
During the hospitalization of the baby
Method of measurement
By Ophthalmologist retina subspecialties

3

Description
Intraventricular hemorrhage
Timepoint
During the hospitalization of the baby
Method of measurement
Brain sonography by pediatric radiologist

4

Description
Necrotizing enterocollitis
Timepoint
During the hospitalization of the baby
Method of measurement
Clinical sings according to BELL score and abdominal sonography by pediatric radiologist

5

Description
Bronchopulmonary dysplasia
Timepoint
During the hospitalization of the baby
Method of measurement
Clinical signs and radiologic findings

Intervention groups

1

Description
Intervention group: Premature babies with a gestational age of more than 26 weeks need non-invasive mechanical ventilation
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Children"s Hospital
Full name of responsible person
Minoo Fallahi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2828
Email
minou_fallahi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
azarghi@zarghi.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo fallahi
Position
associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2828
Email
minou_fallahi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Fallahi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2828
Email
minou_fallahi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Fallahi
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2828
Email
minou_fallahi@sbmu.ac.ir

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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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