Premature BirthNCT04333563
Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants
A study testing CPAP and NIV NAVA in people with Premature Birth and Respiratory Distress Syndrome, Newborn, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 24 to 96 hours
- Conditions the study is for
- Premature Birth, Respiratory Distress Syndrome, Newborn
- What is being tested?
- CPAP and NIV NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 14 Apr 2020to 30 Apr 2022
- Phase
- Interventional
- 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 24 to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- spontaneously breathing preterm infants 24 to 96 hours old
- gestational age (GA) between week 28+0 and 31+6
- preterm infants with GA < 28+0 with a postmenstrual age (PMA) > 28 weeks
- at least 72 hours old treated with CPAP or NIV NAVA
Who cannot join
- preterm infants with severe congenital malformation
- need for vasopressors
- preterm children in need of a specific respiratory support system due to medical reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants: A Randomized Crossover Study
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.
Read the detailed description
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.
- Being tested
- CPAP, NIV NAVA
- Keywords
- Infants, preterm, Respiration, Artificial, Diaphragm, Intensive Care Units, Neonatal, Continuous Positive Airway Pressure, Non invasive neurally adjusted ventilator assist
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Continuous positive airway pressure
NIV NAVADevice
Non-invasive neurally adjusted ventilatory assist
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | respiratory stressed infants getting Continuous positive airway pressure (CPAP) Receives: Device: CPAP; Device: NIV NAVA |
| respiratory stressed infants getting NIV NAVA | Experimental | respiratory stressed infants getting Non-invasive neurally adjusted ventilatory assist (NIV NAVA) Receives: Device: CPAP; Device: NIV NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical activity of the diaphragm
Electromyography signals from the diaphragm in 30 second intervals
Measured: 9 hours and 30 minutes
Secondary outcomes (8)
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.
Measured: Three minutes
Scoring blinded for the intervention
During each intervention, the infants will be video recorded for a blinded assessment.
Measured: 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.
Measured: Three minutes
Parents opinion about the outcomes
Three questions about their opinion about the interventions in a 5 point Likert scale
Measured: Three minutes
Respiratory rate
Standard monitoring on IntelliVue monitor
Measured: 30 second intervals
Heart rate
Standard monitoring on IntelliVue monitor
Measured: 30 second intervals
Oxygen saturation
Standard monitoring on IntelliVue monitor
Measured: 30 second intervals
number of apneic episodes ≥ 20 seconds
Using trend function on the IntelliVue monitor
Measured: 9 hours and 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start14 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Elisabeth Selvaag, md, Study director, St Olavs Hospital, Barne- og ungdomsklinikk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333563
- Sponsor's protocol ID
- 58386
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol Statistical analysis Informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT04333563
- Acronym / sponsor ID
- 58386
- Keywords
- Infants, preterm, Respiration, Artificial, Diaphragm, Intensive Care Units, Neonatal, Continuous Positive Airway Pressure, Non invasive neurally adjusted ventilator assist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Apr 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: CPAP, Device: NIV NAVArespiratory stressed infants getting Continuous positive airway pressure (CPAP) |
| respiratory stressed infants getting NIV NAVA | Experimental | Device: CPAP, Device: NIV NAVArespiratory stressed infants getting Non-invasive neurally adjusted ventilatory assist (NIV NAVA) |
Who may qualify
- Ages
- 24 to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- spontaneously breathing preterm infants 24 to 96 hours old
- gestational age (GA) between week 28+0 and 31+6
- preterm infants with GA < 28+0 with a postmenstrual age (PMA) > 28 weeks
- at least 72 hours old treated with CPAP or NIV NAVA
Key exclusion criteria (3 listed)
- preterm infants with severe congenital malformation
- need for vasopressors
- preterm children in need of a specific respiratory support system due to medical reasons
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 |
|---|---|---|
| CPAPContinuous positive airway pressure | Device | CPAP, respiratory stressed infants getting NIV NAVA |
| NIV NAVANon-invasive neurally adjusted ventilatory assist | Device | CPAP, respiratory stressed infants getting NIV NAVA |
Primary outcome
Electrical activity of the diaphragm
Time frame: 9 hours and 30 minutes
Electromyography signals from the diaphragm in 30 second intervals
8 secondary outcomes
Silverman Andersen Respiratory Severity Score
Time frame: Three minutes
Scoring blinded for the intervention
Time frame: Three minutes video-recording
COMFORTneo pain scale
Time frame: Three minutes
Parents opinion about the outcomes
Time frame: Three minutes
Respiratory rate
Time frame: 30 second intervals
Heart rate
Time frame: 30 second intervals
Oxygen saturation
Time frame: 30 second intervals
number of apneic episodes ≥ 20 seconds
Time frame: 9 hours and 30 seconds
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 15 Jul 2022.
- Individual participant dataSharing planned: Yes. Study protocol Statistical analysis Informed consent form
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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.
Elisabeth Selvaag, md study director
St Olavs Hospital, Barne- og ungdomsklinikk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and NIV NAVA in people with Premature Birth and Respiratory Distress Syndrome, Newborn, run by St. Olavs Hospital at 1 site in Norway.
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 4 inclusion and 3 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 15 Jul 2022. 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 Norway. 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.
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?
Electrical activity of the diaphragm (time frame: 9 hours and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2022.