An interventional study of CPAP and NIV NAVA in Premature Birth and Respiratory Distress Syndrome, Newborn, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 24 Hours to 96 Hours. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment
Strategies to prevent lung injury, facilitate lung development, and to support the preterm infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the gold standard in non-invasive breathing support in preterm infants with a positive pressure that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical activity from the diaphragm to trigger the ventilator and synchronize with the breathing cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the respiratory rate, inspiratory time and peak pressure. This method has the potential to improve the positive pressure transmission to the infant's lower airways, accurate synchronization with the breathing pattern and be a comfortable breathing support system for the preterm infant.
The investigators will compare the effect on breathing effort in preterm infants during continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist measured by electrical activity in the diaphragm, respiratory vital signs, systematic clinical scoring of breathing effort and comfort, and parent reported outcomes.
This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, a 30 minutes period to change the breathing support and a 30 minutes wash out period between interventions. Initially positive end expiratory pressure are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team for both interventions. The neurally adjusted level will be set to obtain average Edi peak \< 15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA) will be individualized according to clinical parameters in each preterm infant.
Modification approved by ethical committee REK 2021, 6th of August:
After two hours in each intervention, the nurse responsible for the infant will perform the clinical scoring. In addition it will be investigated if there is a difference in respiratory vital signs during skin to skin care and in the incubator. During each intervention period, the preterm infants are placed on the parent's chest skin to skin for at least one hour.
A modified version of the scoring tool will be used, i.e. without the item of nasal flaring and expiratory grunting. The headgear for CPAP and NIV NAVA covers parts of the nose and makes nasal flaring difficult to observe.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
respiratory stressed infants getting Continuous positive airway pressure (CPAP)
Device: CPAP · Device: NIV NAVA
respiratory stressed infants getting Non-invasive neurally adjusted ventilatory assist (NIV NAVA)
Device: CPAP · Device: NIV NAVA
Continuous positive airway pressure
Non-invasive neurally adjusted ventilatory assist
Electrical activity of the diaphragm
Electromyography signals from the diaphragm in 30 second intervals
Time frame: 9 hours and 30 minutes
Silverman Andersen Respiratory Severity Score
The scoring tool consists of 5 categories and respiratory distress are graded from zero to two for each category. Respiratory distress gets worse the higher the total score gets.
Time frame: Three minutes
Scoring blinded for the intervention
During each intervention, the infants will be video recorded for a blinded assessment.
Time frame: Three minutes video-recording
COMFORTneo pain scale
Measuring pain and discomfort in a seven category scale graded from 1 - 5, where one is best and five is worse.
Time frame: Three minutes
Parents opinion about the outcomes
Three questions about their opinion about the interventions in a 5 point Likert scale
Time frame: Three minutes
Respiratory rate
Standard monitoring on IntelliVue monitor
Time frame: 30 second intervals
Heart rate
Standard monitoring on IntelliVue monitor
Time frame: 30 second intervals
Oxygen saturation
Standard monitoring on IntelliVue monitor
Time frame: 30 second intervals
number of apneic episodes ≥ 20 seconds
Using trend function on the IntelliVue monitor
Time frame: 9 hours and 30 seconds
Plan to share: Yes — Study protocol Statistical analysis Informed consent form
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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