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Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

Primary Purpose

Infant, Premature, Diseases, Infant, Newborn, Disease, Respiratory Tract Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
noninvasive high frequency oscillatory ventilation
noninvasive positive pressure ventilation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring noninvasive high frequency ventilation, noninvasive ventilation, RDS, post-extubation, preterm, respiratory distress syndrome, noninvasive positive pressure ventilation

Eligibility Criteria

1 Minute - 1 Month (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Preterm neonates with gestational age ≤ 35 weeks.
  2. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation

Exclusion Criteria:

  1. Patients with major upper or lower airway anomalies.
  2. Patients with significant congenital anomalies including cardiac, abdominal or respiratory.

Sites / Locations

  • Neonatal Intensive Care Units (NICUs), Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

noninvasive high frequency oscillatory ventilation (NHFOV)

noninvasive positive pressure ventilation (NIPPV)

Arm Description

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support

Outcomes

Primary Outcome Measures

Re-intubation rate
Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.

Secondary Outcome Measures

Days on the assigned non-invasive respiratory support
To document number of days on the assigned non-invasive respiratory support
Days on supplemental oxygen
To document number of days on supplemental oxygen
Duration of admission
To document total number of days of admission
Mortality rate
To document incidence of mortality during hospitalization
Lung ultrasound score
lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration.
Co2 change
Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.
Oxygen requirement
Fraction of inspired oxygen required to patients on assigned mode
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode.
Days to reach full intake
Number of days needed by each patient to reach full intake
Intracranial hemorrhage
Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode.
Pneumothorax
Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode.
Incidence of occurrence of Nasal trauma
Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode.
incidence of bronchopulmonary dysplasia
Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode.
Severity of respiratory distress
Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing.
Need for Postnatal Steroids
Percentage of patients who needed postnatal steroids administration
Chest x ray change
Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree.

Full Information

First Posted
August 3, 2022
Last Updated
August 7, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05493527
Brief Title
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates
Official Title
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)
Detailed Description
The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown. Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP. The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure. This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP. The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Infant, Newborn, Disease, Respiratory Tract Diseases, RDS
Keywords
noninvasive high frequency ventilation, noninvasive ventilation, RDS, post-extubation, preterm, respiratory distress syndrome, noninvasive positive pressure ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
noninvasive high frequency oscillatory ventilation (NHFOV)
Arm Type
Experimental
Arm Description
After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support
Arm Title
noninvasive positive pressure ventilation (NIPPV)
Arm Type
Active Comparator
Arm Description
After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support
Intervention Type
Device
Intervention Name(s)
noninvasive high frequency oscillatory ventilation
Intervention Description
A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: a frequency of 10 Hertz ( range, 8-12 Hz); an inspiratory time of 50% (1:1) an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.
Intervention Type
Device
Intervention Name(s)
noninvasive positive pressure ventilation
Intervention Description
NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: Peep ranging from 5 to 10 cmH2O, Peak inspiratory pressure range 15-25 cmH2O Rate range 40-50 breath/minute FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.
Primary Outcome Measure Information:
Title
Re-intubation rate
Description
Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Days on the assigned non-invasive respiratory support
Description
To document number of days on the assigned non-invasive respiratory support
Time Frame
8 weeks or till patient discharge which comes first
Title
Days on supplemental oxygen
Description
To document number of days on supplemental oxygen
Time Frame
8 weeks or till patient discharge which comes first
Title
Duration of admission
Description
To document total number of days of admission
Time Frame
8 weeks or till patient discharge which comes first
Title
Mortality rate
Description
To document incidence of mortality during hospitalization
Time Frame
8 weeks or till patient death which comes first
Title
Lung ultrasound score
Description
lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration.
Time Frame
Before extubation and after 2 hours on assigned mode
Title
Co2 change
Description
Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.
Time Frame
Before extubation and after 2 hours on assigned mode
Title
Oxygen requirement
Description
Fraction of inspired oxygen required to patients on assigned mode
Time Frame
Before extubation and after 2 hours on assigned mode
Title
Incidence of feeding intolerance
Description
Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode.
Time Frame
8 weeks or till patient weaning from assigned mode which comes first
Title
Days to reach full intake
Description
Number of days needed by each patient to reach full intake
Time Frame
8 weeks or till patient discharge which comes first
Title
Intracranial hemorrhage
Description
Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode.
Time Frame
8 weeks or till patient weaning from assigned mode which comes first
Title
Pneumothorax
Description
Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode.
Time Frame
8 weeks or till patient weaning from assigned mode which comes first
Title
Incidence of occurrence of Nasal trauma
Description
Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode.
Time Frame
8 weeks or till patient weaning from assigned mode which comes first
Title
incidence of bronchopulmonary dysplasia
Description
Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode.
Time Frame
8 weeks or till patient discharge which comes first
Title
Severity of respiratory distress
Description
Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing.
Time Frame
Before extubation and and after 2 hours on assigned mode
Title
Need for Postnatal Steroids
Description
Percentage of patients who needed postnatal steroids administration
Time Frame
8 weeks or till patient discharge which comes first
Title
Chest x ray change
Description
Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree.
Time Frame
Before extubation and and after 2 hours on assigned mode

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm neonates with gestational age ≤ 35 weeks. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation Exclusion Criteria: Patients with major upper or lower airway anomalies. Patients with significant congenital anomalies including cardiac, abdominal or respiratory.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sondos Ahmed
Phone
0109440704
Ext
202
Email
sondosahmedsalah@gmail.com
Facility Information:
Facility Name
Neonatal Intensive Care Units (NICUs), Ain Shams University
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11517
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sondos Ahmed
Phone
01094407204
Ext
202
Email
sondosahmed@med.asu.edu.eg
Email
sondosahmedsalah@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

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