Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm InfantsPhase 2/3NCT01877720

Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

A Phase 2/3 study testing noninvasive respiratory support with NAVA mode and PSV in people with Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants, run by Seoul National University Hospital at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 days to 3 months
Conditions the study is for: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
What is being tested?: noninvasive respiratory support with NAVA mode and PSV
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 3 sitesSouth Korea
Study dates: Nov 2013to Apr 2014
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 days to 3 months
All sexes
No healthy volunteers
Child

Who may be able to join

preterm infants less than 32 weeks of gestational age
intubated more than 48 hours after birth
subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
with informed consent from parents

Who cannot join

with major congenital anomalies
use of sedative or anesthetic drugs
hemodynamic instability
grade 3 or higher intraventricular hemorrhage
phrenic nerve palsy

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

Seoul National University Bundang Hospital
Bundang, Gyeonggi-do, 463-707
Seoul National University Children's Hospital
Seoul, 110-744
Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants

Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).

Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Being tested: noninvasive respiratory support with NAVA mode and PSV
Keywords: Preterm infant less than 32 weeks of gestation age, intubated more than 48 hours after birth, postextubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

noninvasive respiratory support with NAVA mode and PSVDevice

Study groups in NCT01877720
Study group	Role	What they receive
NAVA-PS	Experimental	noninvasive NAVA first for 15 minutes and then PSV for 15 minutes Receives: Device: noninvasive respiratory support with NAVA mode and PSV
PS-NAVA	Experimental	noninvasive PSV first for 15 minutes and then NAVA for 15 minutes Receives: Device: noninvasive respiratory support with NAVA mode and PSV

What is being measured

The primary outcome is the main question the study is designed to answer.

Trigger Delay
Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.
Measured: last 5-min of each 15-min trial

Secondary outcomes (13)

Ti_excess (Inspiratory Time in Excess)
Ti_excess = (VPT-NIT)/NIT
VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value
Measured: last 5-min of each 15-min trial
Minute Ventilation Volume
inspiratory tidal volume / respiratory rate
Measured: last 5-min of each 15-min trial
Peak Inspiratory Pressure
Measured: last 5-min of each 15-min trial
Pneumatic Respiratory Rate
Measured: last 5-min of each 15-min trial
Maximum EAdi
Measured: last 5-min of each 15-min trial
Swing EAdi
Measured: last 5-min of each 15-min trial
Leakage
[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)
Measured: last 5-min of each 15-min trial
All Asynchrony Events
Measured: last 5-min of each 15-min trial
Asynchrony Index
total number of each event per minute
1. ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization
2. auto-triggering: a cycle delivered by the ventilator without EAdi signal
3. premature cycling
4. delayed cycling: VPT > NIT x2
5. double triggering
- Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100
Measured: last 5-min of each 15-min trial
SpO2
transcutaneous peripheral saturation of oxygen by pulse oximeter
Measured: last 5-min of each 15-min trial
Heart Rate
Measured: last 5-min of each 15-min trial
Blood Pressure
systolic, diastolic and mean blood pressure measured by non-invasive cuff
Measured: last 5-min of each 15-min trial
Respiratory Rate
Measured: last 5-min of each 15-min trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Apr 2014

First posted14 Jun 2013 (estimated)
Study startNov 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm InfantsStudies of the same condition, open and under way.
More trials run by Seoul National University 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01877720
Sponsor's protocol ID: NIV-NAVA Physiologic Study
Status last verified: Nov 2015
First submitted: 5 Jun 2013
Last updated: 23 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.
PubMed 26178463

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
ClinicalTrials.gov ID: NCT01877720
Acronym / sponsor ID: NIV-NAVA Physiologic Study
Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Keywords: Preterm infant less than 32 weeks of gestation age, intubated more than 48 hours after birth, postextubation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Rotary
Study start: Nov 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 14 Jun 2013 (estimated)
Results: Posted 23 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NAVA-PS	Experimental	Device: noninvasive respiratory support with NAVA mode and PSVnoninvasive NAVA first for 15 minutes and then PSV for 15 minutes
PS-NAVA	Experimental	Device: noninvasive respiratory support with NAVA mode and PSVnoninvasive PSV first for 15 minutes and then NAVA for 15 minutes

Who may qualify

Ages: 3 days to 3 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

preterm infants less than 32 weeks of gestational age
intubated more than 48 hours after birth
subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
with informed consent from parents

Key exclusion criteria (5 listed)

with major congenital anomalies
use of sedative or anesthetic drugs
hemodynamic instability
grade 3 or higher intraventricular hemorrhage
phrenic nerve palsy

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
noninvasive respiratory support with NAVA mode and PSV	Device	NAVA-PS, PS-NAVA

Primary outcome

Trigger Delay
Time frame: last 5-min of each 15-min trial
Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.

13 secondary outcomes

Ti_excess (Inspiratory Time in Excess)
Time frame: last 5-min of each 15-min trial
Minute Ventilation Volume
Time frame: last 5-min of each 15-min trial
Peak Inspiratory Pressure
Time frame: last 5-min of each 15-min trial
Pneumatic Respiratory Rate
Time frame: last 5-min of each 15-min trial
Maximum EAdi
Time frame: last 5-min of each 15-min trial
Swing EAdi
Time frame: last 5-min of each 15-min trial
Leakage
Time frame: last 5-min of each 15-min trial
All Asynchrony Events
Time frame: last 5-min of each 15-min trial
Asynchrony Index
Time frame: last 5-min of each 15-min trial
SpO2
Time frame: last 5-min of each 15-min trial
Heart Rate
Time frame: last 5-min of each 15-min trial
Blood Pressure
Time frame: last 5-min of each 15-min trial
Respiratory Rate
Time frame: last 5-min of each 15-min trial

Results and safety

Results posted to the registry on 23 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PS-NAVA	8	7
NAVA-PS	8	8

Primary outcome: Trigger Delay

Time frame: last 5-min of each 15-min trial. Mean (Standard Deviation). Unit: ms

Measure	NIV-NAVA n = 15	NIV-PS n = 15
Value	35.2 (8.3)	294.6 (101.9)

NIV-NAVA vs NIV-PS: p <0.001, Paired t-test

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIV-NAVA	0 of 15 (0%)	0 of 15 (0%)	Not reported
NIV-PS	0 of 15 (0%)	1 of 15 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26178463Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

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.

Han-Suk Kim, MD, PhD principal investigator

Seoul National University Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Trigger Delay (time frame: last 5-min of each 15-min trial). 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 NCT01877720, which also lists 1 linked publication.

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 23 Dec 2015.