Clinical trial NCT04404816: Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome
Official title: Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Distress Syndrome
Premature Infants
Keywords: heliox
respiratory distress syndrome (RDS)
non-invasive ventilation
NIRS
EaDI
Edi
NIV
NAVA
helium-oxygen
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: European Society for Paediatric Research
First posted: 2020-05-28
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

Detailed description: Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.

Eligibility criteria: Inclusion Criteria (Group 1):

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

Inclusion Criteria (Group 2):

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

Exclusion Criteria:

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

Primary outcomes:
measure: baseline minimal electric activity of the diaphragm (EaDI min)
timeFrame: measured at baseline
measure: baseline mean electric activity of the diaphragm (EaDI mean)
timeFrame: measured at baseline
measure: baseline maximal electric activity of the diaphragm (EaDI max)
timeFrame: measured at baseline
measure: minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: baseline PIP (peak inspiratory pressure)
timeFrame: measured at baseline
measure: baseline PEEP (positive end-expiratory pressure)
timeFrame: measured at baseline
measure: baseline MAP (mean airway pressure)
timeFrame: measured at baseline
measure: PIP (peak inspiratory pressure) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: PIP (peak inspiratory pressure) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: PIP (peak inspiratory pressure) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: PIP (peak inspiratory pressure) after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: PIP (peak inspiratory pressure) after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: PIP (peak inspiratory pressure) after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: PEEP (positive end-expiratory pressure) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: PEEP (positive end-expiratory pressure) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: PEEP (positive end-expiratory pressure) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: MAP (mean airway pressure) after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: MAP (mean airway pressure) after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: MAP (mean airway pressure) after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: MAP (mean airway pressure) after 15 minutes of standard ventilation
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: MAP (mean airway pressure) after 60 minutes of standard ventilation
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: MAP (mean airway pressure) after 180 minutes of standard ventilation
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
measure: baseline NIV leakage
timeFrame: measured at baseline
measure: NIV leakage after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: NIV leakage after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: NIV leakage after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: NIV leakage after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to ventilation with standard mixture
measure: NIV leakage after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to ventilation with standard mixture
measure: NIV leakage after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to ventilation with standard mixture
Secondary outcomes:
measure: baseline cerebral oxygenation
timeFrame: measured at baseline
measure: Cerebral oxygenation after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: Cerebral oxygenation after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: Cerebral oxygenation after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: Cerebral oxygenation after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to standard mixture ventilation
measure: Cerebral oxygenation after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to standard mixture ventilation
measure: Cerebral oxygenation after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to standard mixture ventilation
measure: baseline oxygen requirements
timeFrame: recorded at baseline
measure: oxygen requirements after 15 minutes of heliox
timeFrame: recorded after 15 minutes of heliox ventilation
measure: oxygen requirements after 60 minutes of heliox
timeFrame: recorded after 60 minutes of heliox ventilation
measure: oxygen requirements after 180 minutes of heliox
timeFrame: recorded after 180 minutes of heliox ventilation
measure: oxygen requirements after 15 minutes of standard ventilation
timeFrame: recorded after 15 minutes since the return to standard mixture ventilation
measure: oxygen requirements after 60 minutes of standard ventilation
timeFrame: recorded after 60 minutes since the return to standard mixture ventilation
measure: oxygen requirements after 180 minutes of standard ventilation
timeFrame: recorded after 180 minutes since the return to standard mixture ventilation
measure: baseline capillary blood gas analysis
timeFrame: blood samples drawn at baseline
measure: capillary blood gas analysis after 3 hours of heliox
timeFrame: blood samples drawn after 3 hours of heliox ventilation
measure: capillary blood gas analysis after 3 hours of standard mixture
timeFrame: blood samples drawn after 3 hours of standard mixture ventilation
measure: baseline heart rate
timeFrame: measured at baseline
measure: heart rate after 15 minutes of heliox
timeFrame: measured after 15 minutes of heliox ventilation
measure: heart rate after 60 minutes of heliox
timeFrame: measured after 60 minutes of heliox ventilation
measure: heart rate after 180 minutes of heliox
timeFrame: measured after 180 minutes of heliox ventilation
measure: heart rate after 15 minutes of standard mixture
timeFrame: measured after 15 minutes since the return to standard mixture ventilation
measure: heart rate after 60 minutes of standard mixture
timeFrame: measured after 60 minutes since the return to standard mixture ventilation
measure: heart rate after 180 minutes of standard mixture
timeFrame: measured after 180 minutes since the return to standard mixture ventilation
measure: baseline oxygen saturation
timeFrame: measured at baseline
measure: oxygen saturation after 15 minutes of heliox
timeFrame: measured 15 minutes after heliox ventilation
measure: oxygen saturation after 60 minutes of heliox
timeFrame: measured 60 minutes after heliox ventilation
measure: oxygen saturation after 180 minutes of heliox
timeFrame: measured 180 minutes after heliox ventilation
measure: oxygen saturation after 15 minutes of standard mixture
timeFrame: measured 15 minutes since the return to standard mixture ventilation
measure: oxygen saturation after 60 minutes of standard mixture
timeFrame: measured 60 minutes since the return to standard mixture ventilation
measure: oxygen saturation after 180 minutes of standard mixture
timeFrame: measured 180 minutes since the return to standard mixture ventilation
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33
state: Great Poland
Study officials:
affiliation: Department of Neonatology - Poznan University of Medical Sciences
name: Tomasz Szczapa, M.D. PhD
role: STUDY_DIRECTOR
References:
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