Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates

March 11, 2020 updated by: Taipei Medical University Hospital

Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates

Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm. The aims of the study are: 1. To select the appropriate ventilation mode and parameters (for example, switch to NIV-NAVA mode); 2. To monitor intermittent apnea, bradycardia and the frequency of cyanosis, 3. To pay attention to the changes in maximum peak pressure, adjust appropriate pressure support, and avoid lung injury. The predicted outcomes of NAVA mode for premature neonate may include : 1. Measurement of the lower PIP value to maintain proper and synchronized ventilation; 2. Monitoring of the diaphragm activity (Edi) signal to evaluate the work of breathing and estimate the weaning time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 802
        • Hsin-yu LI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature >30week and have Respiratory distress

Description

Inclusion Criteria:

  1. Premature >30week
  2. Respiratory distress

Exclusion Criteria:

  1. Premature < 30weeks
  2. ENT contraindication: fistula
  3. Contraindication with orogastric tube or nasogastric

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NIN-NAVA
  • Premature>30weeks with respiratory distress
  • PI to determine eligibility or exclusion
  • Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization
  • PI will not be blinded to the intervention (not feasible)
  • Place the catheter to optimize position
  • ABG or VBG to be obtained at 2 hrs. post NIV-NAVA
  • NIV-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol
Procedure: NIV-NAVA
NAVA mode during Non-invasive ventilation
Active Comparator: Nasal CPAP or NIMV
  • Premature>30weeks with respiratory distress
  • PI to determine eligibility or exclusion
  • Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization
  • PI will not be blinded to the intervention (not feasible)
  • Place the catheter to optimize position
  • ABG or VBG to be obtained at 2 hrs. post Nasal CPAP or NIMV
  • NCPAP or NIMV settings will be weaned or increased as the clinical situation demands and outlined in the protocol
Procedure: Nasal CPAP or NIMV mode
Nasal CPAP or NIMV mode during Non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: Until the date of discharge from ICU, up to 4 weeks
Defined as the time from the start of mechanical ventilation, defined as either the time of in the ICU and until successful weaning mechanical ventilator, with successful weaning defined as ≥5 days of unassisted spontaneous breathing after .
Until the date of discharge from ICU, up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily patient physiological blood gas status
Time Frame: Until the date of discharge from ICU, up to 4 weeks
Defined as daily PaO2/FiO2 from randomization until successful Weaning.
Until the date of discharge from ICU, up to 4 weeks
Length of ICU stay
Time Frame: Until the date of discharge from ICU, up to 4 weeks
Defined as the duration of ICU admission from randomization to ICU discharge
Until the date of discharge from ICU, up to 4 weeks
Length of hospital stay
Time Frame: Until the date of discharge from ICU, up to 4 weeks
Defined as the duration of hospital admission from randomization to hospital discharge
Until the date of discharge from ICU, up to 4 weeks
Difference in the number of patient ventilator asynchrony
Time Frame: Entire period of ventilatory support, an average of 7 days
To assess the difference of number of patient ventilator asynchrony
Entire period of ventilatory support, an average of 7 days
Ventilation parameters: peak inspiratory pressure in NIV-NAVA
Time Frame: Entire period of ventilatory support, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Entire period of ventilatory support, an average of 7 days
Ventilation parameters : tidal volume in NIV-NAVA
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
through study completion, an average of 7 days
Ventilation parameters : PEEP in NIV-NAVA
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
through study completion, an average of 7 days
Ventilation parameters : FiO2 in NIV-NAVA
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
through study completion, an average of 7 days
Ventilation parameters : Edi peak in NIV-NAVA
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
through study completion, an average of 7 days
Ventilation parameters : Edi min in NIV-NAVA
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
through study completion, an average of 7 days
Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC Level, RR)
through study completion, an average of 7 days
Ventilation parameters : tidal volume in NCPA(or NIMV)
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
through study completion, an average of 7 days
Ventilation parameters : PEEP in NCPA (or NIMV)
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PCl, RR)
through study completion, an average of 7 days
Ventilation parameters : FiO2 in NCPA or NIMV
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
through study completion, an average of 7 days
Ventilation parameters : pressure control level in NIMV
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
through study completion, an average of 7 days
Ventilation parameters : RR in NIMV
Time Frame: through study completion, an average of 7 days
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
through study completion, an average of 7 days
Clinical parameters of Premature: heart rate in NIV-NAVA
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: respiratory rate in NIV-NAVA
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: SpO2 in NIV-NAVA
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (SpO2) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: blood pressure in NIV-NAVA
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: heart rate in NCPA(or NIMV)
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: blood pressure in NCPA (or NIMV)
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
through study completion, an average of 7days
Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)
Time Frame: through study completion, an average of 7days
Evolution of clinical parameters (SpO2) at the beginning and end of each period
through study completion, an average of 7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsin-yu LI, Taipei Medical University Hospital, Taiwan, R.O.C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N201907028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting in January 2022

IPD Sharing Access Criteria

starting in January 2022

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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