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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Premature Infants
• Intervention / Treatment: Drug: heliox

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Poland
  • Great Poland
    • Poznań, Great Poland, Poland, 60-535
      • Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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	Drug: heliox; 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.; Other Names: helium-oxygen gas mixture
Experimental: Group 2; premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt	Drug: heliox; 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.; Other Names: helium-oxygen gas mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 after 180 minutes since the return to ventilation with standard mixture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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 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	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	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	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	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	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	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	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.	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.	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.	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 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 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 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 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 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 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 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 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 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 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 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 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 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 180 minutes since the return to standard mixture ventilation

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Collaborators: European Society for Paediatric Research
• Investigators: Study Director: Tomasz Szczapa, M.D. PhD, Department of Neonatology - Poznan University of Medical Sciences

Publications and helpful links

General 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.
• Elleau 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. Erratum In: J Pediatr 1993 Aug;123(2):336.
• Colnaghi 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.
• Szczapa 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.
• Szczapa 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.
• Jassar 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.
• Sinderby 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.
• Beck 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.
• Brooks 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.
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Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: NIV; non-invasive ventilation; NIRS; NAVA; Edi; heliox; respiratory distress syndrome (RDS); EaDI; helium-oxygen
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 072015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No