Endotracheal ExtubationNCT02590757
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study
A study testing NIV-NAVA and N-CPAP in people with Endotracheal Extubation and Infant, Premature, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation. Read more about this study
- Who is it for?
- Ages 2 days to 6 weeks
- Conditions the study is for
- Endotracheal Extubation, Infant, Premature
- What is being tested?
- NIV-NAVA and N-CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2015to 23 Jan 2021
- 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 2 days to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- postconceptional age less than 30+0 weeks
- infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3
Who cannot join
- conditions which will decrease life expectancy
- major anomalies which will decrease life expectancy
- any anomalous conditions which involve upper and lower airway
- neuromuscular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Official title: Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study
This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation.
- Conditions
- Endotracheal Extubation, Infant, Premature
- Being tested
- NIV-NAVA, N-CPAP
- Keywords
- non-invasive ventilation, non-invasive neurally adjusted ventilatory assist, nasal continuous positive airway pressure
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV-NAVADevice
Non-invasive neurally adjusted ventilatory assist
N-CPAPDevice
Nasal-continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| NIV-NAVA | Active comparator | Noninvasive ventilation in this group is practiced with NIV-NAVA Receives: Device: NIV-NAVA |
| N-CPAP | Active comparator | Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit. Receives: Device: N-CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Failure criteria
- pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
- Severe apnea event requiring bag and mask resuscitation
- FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
- Frequent desaturations (< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0
Measured: extubation - 72 hours
Secondary outcomes (10)
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Participants will be followed for the extubation failure within 3 days after extubation
Measured: extubation - 72 hours
Severe apnea event requiring bag and mask resuscitation
Participants will be followed for the extubation failure within 3 days after extubation
Measured: extubation - 72 hours
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Participants will be followed for the extubation failure within 7 days after extubation
Measured: extubation - 7 days
pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
Participants will be followed for the extubation failure within 7 days after extubation
Measured: extubation - 7 days
Severe apnea event requiring bag and mask resuscitation
Participants will be followed for the extubation failure within 7 days after extubation
Measured: extubation - 7 days
Bronchopulmonary dysplasia
Participants will be followed for the duration of hospital stay
Measured: postmenstrual age 36 weeks
Duration of noninvasive ventilation
Participants will be followed for the duration of hospital stay
Measured: postmenstrual age 40 weeks (until discharge)
Duration of inspired oxygen supply
Participants will be followed for the duration of hospital stay
Measured: postmenstrual age 40 weeks (until discharge)
Duration of hospital stay
Participants will be followed for the duration of hospital stay
Measured: postmenstrual age 40 weeks (until discharge)
Adverse events
Participants will be followed for 3 days after extubation
Measured: extubation - 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start10 Dec 2015
- Primary completion13 Nov 2020
- Study completion23 Jan 2021
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 Endotracheal ExtubationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han-Suk Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590757
- Sponsor's protocol ID
- 2015-1917
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2015
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20.
PubMed 35460702
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02590757
- Acronym / sponsor ID
- 2015-1917
- Conditions
- Endotracheal Extubation, Infant, Premature
- Keywords
- non-invasive ventilation, non-invasive neurally adjusted ventilatory assist, nasal continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 29 Oct 2015 (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 a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV-NAVA | Active comparator | Device: NIV-NAVANoninvasive ventilation in this group is practiced with NIV-NAVA |
| N-CPAP | Active comparator | Device: N-CPAPPatients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit. |
Who may qualify
- Ages
- 2 days to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- postconceptional age less than 30+0 weeks
- infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3
Key exclusion criteria (4 listed)
- conditions which will decrease life expectancy
- major anomalies which will decrease life expectancy
- any anomalous conditions which involve upper and lower airway
- neuromuscular disease
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 |
|---|---|---|
| NIV-NAVANon-invasive neurally adjusted ventilatory assist | Device | NIV-NAVA |
| N-CPAPNasal-continuous positive airway pressure | Device | N-CPAP |
Primary outcome
Extubation failure
Time frame: extubation - 72 hours
Failure criteria * pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings * Severe apnea event requiring bag and mask resuscitation * FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation * Frequent desaturations (< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0
10 secondary outcomes
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Time frame: extubation - 72 hours
Severe apnea event requiring bag and mask resuscitation
Time frame: extubation - 72 hours
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Time frame: extubation - 7 days
pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
Time frame: extubation - 7 days
Severe apnea event requiring bag and mask resuscitation
Time frame: extubation - 7 days
Bronchopulmonary dysplasia
Time frame: postmenstrual age 36 weeks
Duration of noninvasive ventilation
Time frame: postmenstrual age 40 weeks (until discharge)
Duration of inspired oxygen supply
Time frame: postmenstrual age 40 weeks (until discharge)
Duration of hospital stay
Time frame: postmenstrual age 40 weeks (until discharge)
Adverse events
Time frame: extubation - 3days
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 7 Dec 2021.
- Derived from this study: PubMed 35460702Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20.
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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.
Han-Suk Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV-NAVA and N-CPAP in people with Endotracheal Extubation and Infant, Premature, run by Seoul National 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 2 inclusion and 4 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 7 Dec 2021. 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?
Extubation failure (time frame: extubation - 72 hours). 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 NCT02590757, 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 7 Dec 2021.