Respiratory Distress SyndromePhase 1/2NCT04404816
Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome
A Phase 1/2 study testing heliox in people with Respiratory Distress Syndrome and Premature Infants, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour and older
- Conditions the study is for
- Respiratory Distress Syndrome, Premature Infants
- What is being tested?
- heliox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- GA under 33 weeks GA
Show all 9Show fewer
- Need for MV due to clinical symptoms of respiratory distress
- at least one failed attempted extubation
- Parental consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33
Poznan, Great Poland, 60-535
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Premature Infants
- Being tested
- heliox
- Keywords
- heliox, respiratory distress syndrome (RDS), non-invasive ventilation, NIRS, EaDI, Edi, NIV, NAVA, helium-oxygen
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helioxDrug
Also called helium-oxygen gas mixture
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Drug: heliox |
| Group 2 | Experimental | premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt Receives: Drug: heliox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: measured at baseline
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).
Measured: measured at baseline
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).
Measured: measured at baseline
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).
Measured: measured after 15 minutes of heliox 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).
Measured: measured after 15 minutes of heliox 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).
Measured: measured after 15 minutes of heliox 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).
Measured: measured after 60 minutes of heliox 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).
Measured: measured after 60 minutes of heliox 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).
Measured: measured after 60 minutes of heliox 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).
Measured: measured after 180 minutes of heliox 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).
Measured: measured after 180 minutes of heliox 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).
Measured: measured after 180 minutes of heliox 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).
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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).
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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.
Measured: measured at baseline
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.
Measured: measured at baseline
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.
Measured: measured at baseline
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 180 minutes since the return to ventilation with standard mixture
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.
Measured: measured at baseline
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 15 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 60 minutes since the return to ventilation with standard mixture
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.
Measured: measured after 180 minutes since the return to ventilation with standard mixture
Secondary outcomes (31)
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.
Measured: measured at baseline
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 15 minutes since the return to standard mixture ventilation
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.
Measured: measured after 60 minutes since the return to standard mixture ventilation
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.
Measured: measured after 180 minutes since the return to standard mixture ventilation
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
Measured: recorded at baseline
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
Measured: recorded after 15 minutes of heliox ventilation
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
Measured: recorded after 60 minutes of heliox ventilation
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
Measured: recorded after 180 minutes of heliox ventilation
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
Measured: recorded after 15 minutes since the return to standard mixture ventilation
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
Measured: recorded after 60 minutes since the return to standard mixture ventilation
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
Measured: recorded after 180 minutes since the return to standard mixture ventilation
baseline capillary blood gas analysis
Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
Measured: blood samples drawn at baseline
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.
Measured: blood samples drawn after 3 hours of heliox ventilation
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.
Measured: blood samples drawn after 3 hours of standard mixture ventilation
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.
Measured: measured at baseline
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.
Measured: measured after 15 minutes of heliox ventilation
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.
Measured: measured after 60 minutes of heliox ventilation
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.
Measured: measured after 180 minutes of heliox ventilation
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.
Measured: measured after 15 minutes since the return to standard mixture ventilation
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.
Measured: measured after 60 minutes since the return to standard mixture ventilation
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.
Measured: measured after 180 minutes since the return to standard mixture ventilation
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.
Measured: measured at baseline
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.
Measured: measured 15 minutes after heliox ventilation
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.
Measured: measured 60 minutes after heliox ventilation
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.
Measured: measured 180 minutes after heliox ventilation
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.
Measured: measured 15 minutes since the return to standard mixture ventilation
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.
Measured: measured 60 minutes since the return to standard mixture ventilation
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.
Measured: measured 180 minutes since the return to standard mixture ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Paediatric Research
- Responsible party
- Principal investigator, Tomasz Szczapa, Poznan University of Medical Sciences
- Investigators
- Tomasz Szczapa, M.D. PhD, Study director, Department of Neonatology - Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404816
- Sponsor's protocol ID
- 072015
- Status last verified
- Jun 2020
- First submitted
- 5 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
PubMed 23736015Elleau C, Galperine RI, Guenard H, Demarquez JL. Helium-oxygen mixture in respiratory distress syndrome: a double-blind study. J Pediatr. 1993 Jan;122(1):132-6. doi: 10.1016/s0022-3476(05)83506-1.
PubMed 8419600Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
PubMed 22291116Szczapa T, Gadzinowski J, Moczko J, Merritt TA. Heliox for mechanically ventilated newborns with bronchopulmonary dysplasia. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F128-33. doi: 10.1136/archdischild-2013-303988. Epub 2013 Nov 15.
PubMed 24239984Szczapa T, Gadzinowski J. Use of heliox in the management of neonates with meconium aspiration syndrome. Neonatology. 2011;100(3):265-70. doi: 10.1159/000327531. Epub 2011 Jun 23.
PubMed 21701217Jassar RK, Vellanki H, Zhu Y, Hesek A, Wang J, Rodriguez E, Wu J, Shaffer TH, Wolfson MR. High flow nasal cannula (HFNC) with Heliox decreases diaphragmatic injury in a newborn porcine lung injury model. Pediatr Pulmonol. 2014 Dec;49(12):1214-22. doi: 10.1002/ppul.23000. Epub 2014 Feb 5.
PubMed 24500982Sinderby C, Beck J, Spahija J, Weinberg J, Grassino A. Voluntary activation of the human diaphragm in health and disease. J Appl Physiol (1985). 1998 Dec;85(6):2146-58. doi: 10.1152/jappl.1998.85.6.2146.
PubMed 9843538Beck J, Reilly M, Grasselli G, Qui H, Slutsky AS, Dunn MS, Sinderby CA. Characterization of neural breathing pattern in spontaneously breathing preterm infants. Pediatr Res. 2011 Dec;70(6):607-13. doi: 10.1203/PDR.0b013e318232100e.
PubMed 21857389Brooks LJ, DiFiore JM, Martin RJ. Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Pediatr Pulmonol. 1997 Jun;23(6):429-33. doi: 10.1002/(sici)1099-0496(199706)23:63.0.co;2-d.
PubMed 9220525Nawab US, Touch SM, Irwin-Sherman T, Blackson TJ, Greenspan JS, Zhu G, Shaffer TH, Wolfson MR. Heliox attenuates lung inflammation and structural alterations in acute lung injury. Pediatr Pulmonol. 2005 Dec;40(6):524-32. doi: 10.1002/ppul.20304.
PubMed 16193495Kuligowski J, Escobar J, Quintas G, Lliso I, Torres-Cuevas I, Nunez A, Cubells E, Rook D, van Goudoever JB, Vento M. Analysis of lipid peroxidation biomarkers in extremely low gestational age neonate urines by UPLC-MS/MS. Anal Bioanal Chem. 2014 Jul;406(18):4345-56. doi: 10.1007/s00216-014-7824-6. Epub 2014 May 11.
PubMed 24817352Kuligowski J, Torres-Cuevas I, Quintas G, Rook D, van Goudoever JB, Cubells E, Asensi M, Lliso I, Nunez A, Vento M, Escobar J. Assessment of oxidative damage to proteins and DNA in urine of newborn infants by a validated UPLC-MS/MS approach. PLoS One. 2014 Apr 2;9(4):e93703. doi: 10.1371/journal.pone.0093703. eCollection 2014.
PubMed 24695409Oei GT, Weber NC, Hollmann MW, Preckel B. Cellular effects of helium in different organs. Anesthesiology. 2010 Jun;112(6):1503-10. doi: 10.1097/ALN.0b013e3181d9cb5e.
PubMed 20460992
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04404816
- Acronym / sponsor ID
- 072015
- Conditions
- Respiratory Distress Syndrome, Premature Infants
- Keywords
- heliox, respiratory distress syndrome (RDS), non-invasive ventilation, NIRS, EaDI, Edi, NIV, NAVA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- European Society for Paediatric Research
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: helioxpremature 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 |
| Group 2 | Experimental | Drug: helioxpremature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt |
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| helioxAlso: helium-oxygen gas mixtureNIV-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. | Drug | Group 1, Group 2 |
Primary outcome
baseline minimal electric activity of the diaphragm (EaDI min)
Time frame: measured at baseline
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)
Time frame: measured at baseline
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)
Time frame: measured at baseline
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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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)
Time frame: measured at baseline
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)
Time frame: measured at baseline
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)
Time frame: measured at baseline
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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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
Time frame: measured after 15 minutes of heliox 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 heliox
Time frame: measured after 60 minutes of heliox 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 heliox
Time frame: measured after 180 minutes of heliox 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 15 minutes of standard ventilation
Time frame: measured after 180 minutes since the return to ventilation with standard mixture
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
Time frame: measured after 60 minutes since the return to ventilation with standard mixture
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
Time frame: measured after 180 minutes since the return to ventilation with standard mixture
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
Time frame: measured at baseline
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
Time frame: measured after 15 minutes of heliox ventilation
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
Time frame: measured after 60 minutes of heliox ventilation
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
Time frame: measured after 180 minutes of heliox ventilation
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
Time frame: measured after 15 minutes since the return to ventilation with 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
Time frame: measured after 60 minutes since the return to ventilation with 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
Time frame: measured after 180 minutes since the return to ventilation with 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.
31 secondary outcomes
baseline cerebral oxygenation
Time frame: measured at baseline
Cerebral oxygenation after 15 minutes of heliox
Time frame: measured after 15 minutes of heliox ventilation
Cerebral oxygenation after 60 minutes of heliox
Time frame: measured after 60 minutes of heliox ventilation
Cerebral oxygenation after 180 minutes of heliox
Time frame: measured after 180 minutes of heliox ventilation
Cerebral oxygenation after 15 minutes of standard mixture
Time frame: measured after 15 minutes since the return to standard mixture ventilation
Cerebral oxygenation after 60 minutes of standard mixture
Time frame: measured after 60 minutes since the return to standard mixture ventilation
Cerebral oxygenation after 180 minutes of standard mixture
Time frame: measured after 180 minutes since the return to standard mixture ventilation
baseline oxygen requirements
Time frame: recorded at baseline
oxygen requirements after 15 minutes of heliox
Time frame: recorded after 15 minutes of heliox ventilation
oxygen requirements after 60 minutes of heliox
Time frame: recorded after 60 minutes of heliox ventilation
oxygen requirements after 180 minutes of heliox
Time frame: recorded after 180 minutes of heliox ventilation
oxygen requirements after 15 minutes of standard ventilation
Time frame: recorded after 15 minutes since the return to standard mixture ventilation
oxygen requirements after 60 minutes of standard ventilation
Time frame: recorded after 60 minutes since the return to standard mixture ventilation
oxygen requirements after 180 minutes of standard ventilation
Time frame: recorded after 180 minutes since the return to standard mixture ventilation
baseline capillary blood gas analysis
Time frame: blood samples drawn at baseline
capillary blood gas analysis after 3 hours of heliox
Time frame: blood samples drawn after 3 hours of heliox ventilation
capillary blood gas analysis after 3 hours of standard mixture
Time frame: blood samples drawn after 3 hours of standard mixture ventilation
baseline heart rate
Time frame: measured at baseline
heart rate after 15 minutes of heliox
Time frame: measured after 15 minutes of heliox ventilation
heart rate after 60 minutes of heliox
Time frame: measured after 60 minutes of heliox ventilation
heart rate after 180 minutes of heliox
Time frame: measured after 180 minutes of heliox ventilation
heart rate after 15 minutes of standard mixture
Time frame: measured after 15 minutes since the return to standard mixture ventilation
heart rate after 60 minutes of standard mixture
Time frame: measured after 60 minutes since the return to standard mixture ventilation
heart rate after 180 minutes of standard mixture
Time frame: measured after 180 minutes since the return to standard mixture ventilation
baseline oxygen saturation
Time frame: measured at baseline
oxygen saturation after 15 minutes of heliox
Time frame: measured 15 minutes after heliox ventilation
oxygen saturation after 60 minutes of heliox
Time frame: measured 60 minutes after heliox ventilation
oxygen saturation after 180 minutes of heliox
Time frame: measured 180 minutes after heliox ventilation
oxygen saturation after 15 minutes of standard mixture
Time frame: measured 15 minutes since the return to standard mixture ventilation
oxygen saturation after 60 minutes of standard mixture
Time frame: measured 60 minutes since the return to standard mixture ventilation
oxygen saturation after 180 minutes of standard mixture
Time frame: measured 180 minutes since the return to standard mixture ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 23736015Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
- Background: PubMed 8419600Elleau C, Galperine RI, Guenard H, Demarquez JL. Helium-oxygen mixture in respiratory distress syndrome: a double-blind study. J Pediatr. 1993 Jan;122(1):132-6. doi: 10.1016/s0022-3476(05)83506-1.
- Background: PubMed 22291116Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
- Background: PubMed 24239984Szczapa T, Gadzinowski J, Moczko J, Merritt TA. Heliox for mechanically ventilated newborns with bronchopulmonary dysplasia. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F128-33. doi: 10.1136/archdischild-2013-303988. Epub 2013 Nov 15.
- Background: PubMed 21701217Szczapa T, Gadzinowski J. Use of heliox in the management of neonates with meconium aspiration syndrome. Neonatology. 2011;100(3):265-70. doi: 10.1159/000327531. Epub 2011 Jun 23.
- Background: PubMed 24500982Jassar RK, Vellanki H, Zhu Y, Hesek A, Wang J, Rodriguez E, Wu J, Shaffer TH, Wolfson MR. High flow nasal cannula (HFNC) with Heliox decreases diaphragmatic injury in a newborn porcine lung injury model. Pediatr Pulmonol. 2014 Dec;49(12):1214-22. doi: 10.1002/ppul.23000. Epub 2014 Feb 5.
- Background: PubMed 9843538Sinderby C, Beck J, Spahija J, Weinberg J, Grassino A. Voluntary activation of the human diaphragm in health and disease. J Appl Physiol (1985). 1998 Dec;85(6):2146-58. doi: 10.1152/jappl.1998.85.6.2146.
- Background: PubMed 21857389Beck J, Reilly M, Grasselli G, Qui H, Slutsky AS, Dunn MS, Sinderby CA. Characterization of neural breathing pattern in spontaneously breathing preterm infants. Pediatr Res. 2011 Dec;70(6):607-13. doi: 10.1203/PDR.0b013e318232100e.
- Background: PubMed 9220525Brooks LJ, DiFiore JM, Martin RJ. Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Pediatr Pulmonol. 1997 Jun;23(6):429-33. doi: 10.1002/(sici)1099-0496(199706)23:63.0.co;2-d.
- Background: PubMed 16193495Nawab US, Touch SM, Irwin-Sherman T, Blackson TJ, Greenspan JS, Zhu G, Shaffer TH, Wolfson MR. Heliox attenuates lung inflammation and structural alterations in acute lung injury. Pediatr Pulmonol. 2005 Dec;40(6):524-32. doi: 10.1002/ppul.20304.
- Background: PubMed 24817352Kuligowski J, Escobar J, Quintas G, Lliso I, Torres-Cuevas I, Nunez A, Cubells E, Rook D, van Goudoever JB, Vento M. Analysis of lipid peroxidation biomarkers in extremely low gestational age neonate urines by UPLC-MS/MS. Anal Bioanal Chem. 2014 Jul;406(18):4345-56. doi: 10.1007/s00216-014-7824-6. Epub 2014 May 11.
- Background: PubMed 24695409Kuligowski J, Torres-Cuevas I, Quintas G, Rook D, van Goudoever JB, Cubells E, Asensi M, Lliso I, Nunez A, Vento M, Escobar J. Assessment of oxidative damage to proteins and DNA in urine of newborn infants by a validated UPLC-MS/MS approach. PLoS One. 2014 Apr 2;9(4):e93703. doi: 10.1371/journal.pone.0093703. eCollection 2014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Szczapa, M.D. PhD study director
Department of Neonatology - Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing heliox in people with Respiratory Distress Syndrome and Premature Infants, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline minimal electric activity of the diaphragm (EaDI min) (time frame: measured at baseline). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404816, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.