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Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome, Premature Infants

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
heliox
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Distress Syndrome focused on measuring heliox, respiratory distress syndrome (RDS), non-invasive ventilation, NIRS, EaDI, Edi, NIV, NAVA, helium-oxygen

Eligibility Criteria

1 Hour - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Group 1):

  • GA under 33 weeks GA
  • Need for NIV due to clinical symptoms of respiratory distress in course of RDS
  • FiO2=0.25-0.4
  • Enrollment within first 72 hours of life
  • Parental consent

Inclusion Criteria (Group 2):

  • GA under 33 weeks GA
  • Need for MV due to clinical symptoms of respiratory distress
  • at least one failed attempted extubation
  • Parental consent

Exclusion Criteria:

  • Major congenital anomalies
  • Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)

Sites / Locations

  • Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

premature infants born < 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 <0.4

premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt

Outcomes

Primary Outcome Measures

baseline minimal electric activity of the diaphragm (EaDI min)
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV, microvolts] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline mean electric activity of the diaphragm (EaDI mean)
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline maximal electric activity of the diaphragm (EaDI max)
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline PIP (peak inspiratory pressure)
PIP [cm H2O, centimeters of water] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
baseline PEEP (positive end-expiratory pressure)
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
baseline MAP (mean airway pressure)
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 15 minutes of heliox
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 60 minutes of heliox
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 180 minutes of heliox
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 15 minutes of standard mixture
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 60 minutes of standard mixture
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 180 minutes of standard mixture
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 15 minutes of heliox
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 60 minutes of heliox
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 180 minutes of heliox
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 15 minutes of heliox
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 60 minutes of heliox
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 180 minutes of heliox
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 15 minutes of standard ventilation
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 60 minutes of standard ventilation
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 180 minutes of standard ventilation
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
baseline NIV leakage
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 15 minutes of heliox
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 60 minutes of heliox
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 180 minutes of heliox
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 15 minutes of standard mixture
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 60 minutes of standard mixture
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 180 minutes of standard mixture
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

Secondary Outcome Measures

baseline cerebral oxygenation
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 15 minutes of heliox
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 60 minutes of heliox
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 180 minutes of heliox
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 15 minutes of standard mixture
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 60 minutes of standard mixture
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Cerebral oxygenation after 180 minutes of standard mixture
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
baseline oxygen requirements
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 15 minutes of heliox
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 60 minutes of heliox
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 180 minutes of heliox
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 15 minutes of standard ventilation
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 60 minutes of standard ventilation
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
oxygen requirements after 180 minutes of standard ventilation
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
baseline capillary blood gas analysis
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
capillary blood gas analysis after 3 hours of heliox
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
capillary blood gas analysis after 3 hours of standard mixture
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
baseline heart rate
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 15 minutes of heliox
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 60 minutes of heliox
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 180 minutes of heliox
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 15 minutes of standard mixture
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 60 minutes of standard mixture
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
heart rate after 180 minutes of standard mixture
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
baseline oxygen saturation
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 15 minutes of heliox
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 60 minutes of heliox
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 180 minutes of heliox
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 15 minutes of standard mixture
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 60 minutes of standard mixture
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
oxygen saturation after 180 minutes of standard mixture
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

Full Information

First Posted
May 5, 2020
Last Updated
June 5, 2020
Sponsor
Poznan University of Medical Sciences
Collaborators
European Society for Paediatric Research
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1. Study Identification

Unique Protocol Identification Number
NCT04404816
Brief Title
Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome
Official Title
Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
European Society for Paediatric Research

4. Oversight

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

5. Study Description

Brief Summary
The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.
Detailed Description
Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Premature Infants
Keywords
heliox, respiratory distress syndrome (RDS), non-invasive ventilation, NIRS, EaDI, Edi, NIV, NAVA, helium-oxygen

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
premature infants born < 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 <0.4
Arm Title
Group 2
Arm Type
Experimental
Arm Description
premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt
Intervention Type
Drug
Intervention Name(s)
heliox
Other Intervention Name(s)
helium-oxygen gas mixture
Intervention Description
NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.
Primary Outcome Measure Information:
Title
baseline minimal electric activity of the diaphragm (EaDI min)
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV, microvolts] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured at baseline
Title
baseline mean electric activity of the diaphragm (EaDI mean)
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured at baseline
Title
baseline maximal electric activity of the diaphragm (EaDI max)
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured at baseline
Title
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes of heliox ventilation
Title
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes of heliox ventilation
Title
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes of heliox ventilation
Title
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes of heliox ventilation
Title
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes of heliox ventilation
Title
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes of heliox ventilation
Title
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes of heliox ventilation
Title
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes of heliox ventilation
Title
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes of heliox ventilation
Title
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture
Description
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
baseline PIP (peak inspiratory pressure)
Description
PIP [cm H2O, centimeters of water] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
baseline PEEP (positive end-expiratory pressure)
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
baseline MAP (mean airway pressure)
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
PIP (peak inspiratory pressure) after 15 minutes of heliox
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
PIP (peak inspiratory pressure) after 60 minutes of heliox
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
PIP (peak inspiratory pressure) after 180 minutes of heliox
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
PIP (peak inspiratory pressure) after 15 minutes of standard mixture
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
PIP (peak inspiratory pressure) after 60 minutes of standard mixture
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
PIP (peak inspiratory pressure) after 180 minutes of standard mixture
Description
PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
PEEP (positive end-expiratory pressure) after 15 minutes of heliox
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
PEEP (positive end-expiratory pressure) after 60 minutes of heliox
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
PEEP (positive end-expiratory pressure) after 180 minutes of heliox
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture
Description
PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
MAP (mean airway pressure) after 15 minutes of heliox
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
MAP (mean airway pressure) after 60 minutes of heliox
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
MAP (mean airway pressure) after 180 minutes of heliox
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
MAP (mean airway pressure) after 15 minutes of standard ventilation
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
MAP (mean airway pressure) after 60 minutes of standard ventilation
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
MAP (mean airway pressure) after 180 minutes of standard ventilation
Description
MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Title
baseline NIV leakage
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
NIV leakage after 15 minutes of heliox
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
NIV leakage after 60 minutes of heliox
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
NIV leakage after 180 minutes of heliox
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
NIV leakage after 15 minutes of standard mixture
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes since the return to ventilation with standard mixture
Title
NIV leakage after 60 minutes of standard mixture
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to ventilation with standard mixture
Title
NIV leakage after 180 minutes of standard mixture
Description
gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to ventilation with standard mixture
Secondary Outcome Measure Information:
Title
baseline cerebral oxygenation
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
Cerebral oxygenation after 15 minutes of heliox
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
Cerebral oxygenation after 60 minutes of heliox
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
Cerebral oxygenation after 180 minutes of heliox
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
Cerebral oxygenation after 15 minutes of standard mixture
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes since the return to standard mixture ventilation
Title
Cerebral oxygenation after 60 minutes of standard mixture
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to standard mixture ventilation
Title
Cerebral oxygenation after 180 minutes of standard mixture
Description
Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to standard mixture ventilation
Title
baseline oxygen requirements
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded at baseline
Title
oxygen requirements after 15 minutes of heliox
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 15 minutes of heliox ventilation
Title
oxygen requirements after 60 minutes of heliox
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 60 minutes of heliox ventilation
Title
oxygen requirements after 180 minutes of heliox
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 180 minutes of heliox ventilation
Title
oxygen requirements after 15 minutes of standard ventilation
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 15 minutes since the return to standard mixture ventilation
Title
oxygen requirements after 60 minutes of standard ventilation
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 60 minutes since the return to standard mixture ventilation
Title
oxygen requirements after 180 minutes of standard ventilation
Description
Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
Time Frame
recorded after 180 minutes since the return to standard mixture ventilation
Title
baseline capillary blood gas analysis
Description
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
Time Frame
blood samples drawn at baseline
Title
capillary blood gas analysis after 3 hours of heliox
Description
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
Time Frame
blood samples drawn after 3 hours of heliox ventilation
Title
capillary blood gas analysis after 3 hours of standard mixture
Description
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
Time Frame
blood samples drawn after 3 hours of standard mixture ventilation
Title
baseline heart rate
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
heart rate after 15 minutes of heliox
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes of heliox ventilation
Title
heart rate after 60 minutes of heliox
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes of heliox ventilation
Title
heart rate after 180 minutes of heliox
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes of heliox ventilation
Title
heart rate after 15 minutes of standard mixture
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 15 minutes since the return to standard mixture ventilation
Title
heart rate after 60 minutes of standard mixture
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 60 minutes since the return to standard mixture ventilation
Title
heart rate after 180 minutes of standard mixture
Description
heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured after 180 minutes since the return to standard mixture ventilation
Title
baseline oxygen saturation
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured at baseline
Title
oxygen saturation after 15 minutes of heliox
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 15 minutes after heliox ventilation
Title
oxygen saturation after 60 minutes of heliox
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 60 minutes after heliox ventilation
Title
oxygen saturation after 180 minutes of heliox
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 180 minutes after heliox ventilation
Title
oxygen saturation after 15 minutes of standard mixture
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 15 minutes since the return to standard mixture ventilation
Title
oxygen saturation after 60 minutes of standard mixture
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 60 minutes since the return to standard mixture ventilation
Title
oxygen saturation after 180 minutes of standard mixture
Description
SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
Time Frame
measured 180 minutes since the return to standard mixture ventilation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Group 1): GA under 33 weeks GA Need for NIV due to clinical symptoms of respiratory distress in course of RDS FiO2=0.25-0.4 Enrollment within first 72 hours of life Parental consent Inclusion Criteria (Group 2): GA under 33 weeks GA Need for MV due to clinical symptoms of respiratory distress at least one failed attempted extubation Parental consent Exclusion Criteria: Major congenital anomalies Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Szczapa, M.D. PhD
Organizational Affiliation
Department of Neonatology - Poznan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33
City
Poznań
State/Province
Great Poland
ZIP/Postal Code
60-535
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

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