Respiratory Distress Syndrome In Premature InfantsNCT02770976
Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
A study testing Increasing and decreasing NAVA levels with 10-min intervals in people with Respiratory Distress Syndrome In Premature Infants and Preterm Infants, run by Inha University Hospital at 1 site in South Korea.
Trial summary
This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome In Premature Infants, Preterm Infants
- What is being tested?
- Increasing and decreasing NAVA levels with 10-min intervals
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to 9 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- preterm infants born before 36 weeks of gestational age
- who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
- no use of anesthetics or analgetics
Who cannot join
- with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
- with phrenic nerve palsy or injuries
Trial locations and contacts
1 site in 1 country.
About this study
This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.
- Being tested
- Increasing and decreasing NAVA levels with 10-min intervals
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing and decreasing NAVA levels with 10-min intervalsDevice
| Study group | Role | What they receive |
|---|---|---|
| NAVA | Experimental | Seven increasing and decreasing NAVA levels (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0 and 0.5 cmH2O/uV) will applied to 20 preterm infants each for 10 minutes. Receives: Device: Increasing and decreasing NAVA levels with 10-min intervals |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum Edi
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
Measured: the middle 2 minutes duration out of the total interval of 10 minutes
Secondary outcomes (5)
comfort score
calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
Measured: the 5-min point in the total 10-min period
peak inspiratory pressure
mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
Measured: the middle 2 minutes duration out of the total interval of 10 minutes
tidal volume
mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
Measured: the middle 2 minutes duration out of the total interval of 10 minutes
inspiratory time in excess
mean of calculated excessive inspiratory times from the calculation ((ventilator pressurization time-neural inspiratory time)/neural inspiratory time) from the middle 2 min duration out of the total 10 min period
Measured: the middle 2 minutes duration out of the total interval of 10 minutes
electrical time product
mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period
Measured: the middle 2 minutes duration out of the total interval of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome In Premature InfantsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770976
- Sponsor's protocol ID
- NAVA-03-INV
- Status last verified
- Jan 2018
- First submitted
- 10 May 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
Publications
Nam SK, Lee J, Jun YH. Neural feedback is insufficient in preterm infants during neurally adjusted ventilatory assist. Pediatr Pulmonol. 2019 Aug;54(8):1277-1283. doi: 10.1002/ppul.24352. Epub 2019 May 11.
PubMed 31077579
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
- ClinicalTrials.gov ID
- NCT02770976
- Acronym / sponsor ID
- NAVA-03-INV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- 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.
This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAVA | Experimental | Device: Increasing and decreasing NAVA levels with 10-min intervalsSeven increasing and decreasing NAVA levels (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0 and 0.5 cmH2O/uV) will applied to 20 preterm infants each for 10 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- preterm infants born before 36 weeks of gestational age
- who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
- no use of anesthetics or analgetics
Key exclusion criteria (2 listed)
- with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
- with phrenic nerve palsy or injuries
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 |
|---|---|---|
| Increasing and decreasing NAVA levels with 10-min intervals | Device | NAVA |
Primary outcome
maximum Edi
Time frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
5 secondary outcomes
comfort score
Time frame: the 5-min point in the total 10-min period
peak inspiratory pressure
Time frame: the middle 2 minutes duration out of the total interval of 10 minutes
tidal volume
Time frame: the middle 2 minutes duration out of the total interval of 10 minutes
inspiratory time in excess
Time frame: the middle 2 minutes duration out of the total interval of 10 minutes
electrical time product
Time frame: the middle 2 minutes duration out of the total interval of 10 minutes
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 26 Jan 2018.
- Derived from this study: PubMed 31077579Nam SK, Lee J, Jun YH. Neural feedback is insufficient in preterm infants during neurally adjusted ventilatory assist. Pediatr Pulmonol. 2019 Aug;54(8):1277-1283. doi: 10.1002/ppul.24352. Epub 2019 May 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing and decreasing NAVA levels with 10-min intervals in people with Respiratory Distress Syndrome In Premature Infants and Preterm Infants, run by Inha University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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 26 Jan 2018. 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 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.
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?
maximum Edi (time frame: the middle 2 minutes duration out of the total interval of 10 minutes). 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 NCT02770976, 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 26 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.