Respiratory Distress Syndrome in Premature InfantNCT04118400

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

An observational study of Respiratory Distress Syndrome in Premature Infant, run by Taipei Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 30 to 37 weeks
Conditions the study is for: Respiratory Distress Syndrome in Premature Infant
What is being tested?: NIV-NAVA and Nasal CPAP or NIMV mode
Type of treatment: Surgery or procedure
How many people: 60 participants
Where: 1 siteTaiwan
Study dates: 31 Oct 2019to 31 Aug 2021
How long will I take part?: 2 Months
Phase: Observational
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 30 to 37 weeks
All sexes
No healthy volunteers
Child

Study population: Premature >30week and have Respiratory distress

Who may be able to join

Premature >30week
Respiratory distress

Who cannot join

Premature < 30weeks
ENT contraindication: fistula
Contraindication with orogastric tube or nasogastric

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Hsin-yu LI
Taipei, 802

Other trials in Taiwan

About this study

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

Read the 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.

Conditions: Respiratory Distress Syndrome in Premature Infant
Being tested: NIV-NAVA, Nasal CPAP or NIMV mode

What participants receive

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

NIV-NAVAProcedure or surgery
NAVA mode during Non-invasive ventilation
Nasal CPAP or NIMV modeProcedure or surgery
Nasal CPAP or NIMV mode during Non-invasive ventilation

Study groups in NCT04118400
Study group	Role	What they receive
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 Receives: Procedure: NIV-NAVA
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 Receives: Procedure: Nasal CPAP or NIMV mode

What is being measured

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

Duration of mechanical ventilation
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 .
Measured: Until the date of discharge from ICU, up to 4 weeks

Secondary outcomes (24)

Daily patient physiological blood gas status
Defined as daily PaO2/FiO2 from randomization until successful Weaning.
Measured: Until the date of discharge from ICU, up to 4 weeks
Length of ICU stay
Defined as the duration of ICU admission from randomization to ICU discharge
Measured: Until the date of discharge from ICU, up to 4 weeks
Length of hospital stay
Defined as the duration of hospital admission from randomization to hospital discharge
Measured: Until the date of discharge from ICU, up to 4 weeks
Difference in the number of patient ventilator asynchrony
To assess the difference of number of patient ventilator asynchrony
Measured: Entire period of ventilatory support, an average of 7 days
Ventilation parameters: peak inspiratory pressure in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: Entire period of ventilatory support, an average of 7 days
Ventilation parameters : tidal volume in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: through study completion, an average of 7 days
Ventilation parameters : PEEP in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: through study completion, an average of 7 days
Ventilation parameters : FiO2 in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: through study completion, an average of 7 days
Ventilation parameters : Edi peak in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: through study completion, an average of 7 days
Ventilation parameters : Edi min in NIV-NAVA
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )
Measured: through study completion, an average of 7 days
Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC Level, RR)
Measured: through study completion, an average of 7 days
Ventilation parameters : tidal volume in NCPA(or NIMV)
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
Measured: through study completion, an average of 7 days
Ventilation parameters : PEEP in NCPA (or NIMV)
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PCl, RR)
Measured: through study completion, an average of 7 days
Ventilation parameters : FiO2 in NCPA or NIMV
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
Measured: through study completion, an average of 7 days
Ventilation parameters : pressure control level in NIMV
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
Measured: through study completion, an average of 7 days
Ventilation parameters : RR in NIMV
Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)
Measured: through study completion, an average of 7 days
Clinical parameters of Premature: heart rate in NIV-NAVA
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: respiratory rate in NIV-NAVA
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: SpO2 in NIV-NAVA
Evolution of clinical parameters (SpO2) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: blood pressure in NIV-NAVA
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: heart rate in NCPA(or NIMV)
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: blood pressure in NCPA (or NIMV)
Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 7days
Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)
Evolution of clinical parameters (SpO2) at the beginning and end of each period
Measured: through study completion, an average of 7days

Timeline

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

31 Oct 201931 Aug 2021

First posted8 Oct 2019
Study start31 Oct 2019
Primary completion6 Oct 2020 (estimated)
Study completion31 Aug 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Distress Syndrome in Premature InfantStudies 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 60 participants (estimated)
Target duration: 2 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04118400
Sponsor's protocol ID: N201907028
Status last verified: Oct 2019
First submitted: 2 Oct 2019
Last updated: 12 Mar 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: all IPD that underlie results in a publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress

All Respiratory Distress Syndrome in Premature Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates
ClinicalTrials.gov ID: NCT04118400
Acronym / sponsor ID: N201907028
Conditions: Respiratory Distress Syndrome in Premature Infant
Study type: Observational
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Taipei Medical University HospitalUniversity, hospital or other
Study start: 31 Oct 2019 (actual)
Primary completion: 6 Oct 2020 (estimated)
Study completion: 31 Aug 2021 (estimated)
First posted: 8 Oct 2019 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 2 Months
Number of arms: 2

Arm	Type	Receives
Experimental: NIN-NAVA	–	Procedure: NIV-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
Active Comparator: Nasal CPAP or NIMV	–	Procedure: Nasal CPAP or NIMV mode* 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

Who may qualify

Ages: 30 to 37 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Premature >30week and have Respiratory distress

Key inclusion criteria (2 listed)

Premature >30week
Respiratory distress

Key exclusion criteria (3 listed)

Premature < 30weeks
ENT contraindication: fistula
Contraindication with orogastric tube or nasogastric

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-NAVANAVA mode during Non-invasive ventilation	Procedure or surgery	Experimental: NIN-NAVA
Nasal CPAP or NIMV modeNasal CPAP or NIMV mode during Non-invasive ventilation	Procedure or surgery	Active Comparator: Nasal CPAP or NIMV

Primary outcome

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 .

24 secondary outcomes

Daily patient physiological blood gas status
Time frame: 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
Length of hospital stay
Time frame: 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
Ventilation parameters: peak inspiratory pressure in NIV-NAVA
Time frame: 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
Ventilation parameters : PEEP in NIV-NAVA
Time frame: through study completion, an average of 7 days
Ventilation parameters : FiO2 in NIV-NAVA
Time frame: 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
Ventilation parameters : Edi min in NIV-NAVA
Time frame: 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
Ventilation parameters : tidal volume in NCPA(or NIMV)
Time frame: 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
Ventilation parameters : FiO2 in NCPA or NIMV
Time frame: 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
Ventilation parameters : RR in NIMV
Time frame: 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
Clinical parameters of Premature: respiratory rate in NIV-NAVA
Time frame: through study completion, an average of 7days
Clinical parameters of Premature: SpO2 in NIV-NAVA
Time frame: 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
Clinical parameters of Premature: heart rate in NCPA(or NIMV)
Time frame: 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
Clinical parameters of Premature: blood pressure in NCPA (or NIMV)
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication

Related trials for Respiratory Distress Syndrome in Premature Infant

Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress

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.

Hsin-yu LI principal investigator

Taipei Medical University Hospital, Taiwan, R.O.C

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

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome in Premature Infant, run by Taipei Medical University Hospital at 1 site in Taiwan.

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 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. 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 Taiwan. 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?

Results are not available in the source record.

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?

Duration of mechanical ventilation (time frame: Until the date of discharge from ICU, up to 4 weeks). 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 NCT04118400.

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 12 Mar 2020.