Respiratory InsufficiencyNCT02518230

Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

A study testing Neurally Adjusted Ventilatory Assist and Synchronized Interm. Mandatory Assist in people with Respiratory Insufficiency and Infant, Newborn, Disease, run by Children's Mercy Hospital Kansas City at 1 site in United States.

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

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. Read more about this study

Who is it for?: Ages Up to 24 months
Conditions the study is for: Respiratory Insufficiency, Infant, Newborn, Disease
What is being tested?: Neurally Adjusted Ventilatory Assist and Synchronized Interm. Mandatory Assist
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Jun 2015
Phase: Interventional
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 Up to 24 months
All sexes
No healthy volunteers
Child

Who may be able to join

Neonates and infants, 22 weeks gestation age or older at birth
Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes
Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less.
Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.

Who cannot join

Major congenital anomalies
Neurologic compromise of respiratory drive
Phrenic nerve palsy
Sedated enough to suppress respiratory drive
Respiratory support with volume mechanical ventilation
Respiratory support with high frequency oscillatory ventilation

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Hospital
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV

This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure.

It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

Read the detailed description

This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure.

Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours.

After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

Conditions: Respiratory Insufficiency, Infant, Newborn, Disease
Being tested: Neurally Adjusted Ventilatory Assist, Synchronized Interm. Mandatory Assist
Medical subject headings: Respiratory Insufficiency, Disease

What participants receive

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

Neurally Adjusted Ventilatory AssistDevice
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
Synchronized Interm. Mandatory AssistDevice
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support

Study groups in NCT02518230
Study group	Role	What they receive
Neurally Adjusted Ventilatory Assist	Other	Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist
Synchronized Interm. Mandatory Assist	Other	Subject will be randomized to SIMV(PC)PS ventilation. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist

What is being measured

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

Respiratory Severity Score (MAP X FiO2)
The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.
Measured: 12 hours and 24 hours

Secondary outcomes (1)

Energy Expenditure
The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation.
Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day.
Measured: 12 hours and 24 hours

Timeline

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

Jan 2014Jun 2015

First posted7 Aug 2015 (estimated)
Study startJan 2014
Primary completionJun 2015
Study completionJun 2015

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 Respiratory InsufficiencyStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02518230
Sponsor's protocol ID: Crossover NAVA
Status last verified: Jun 2021
First submitted: 3 Aug 2015
Last updated: 23 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rosterman JL, Pallotto EK, Truog WE, Escobar H, Meinert KA, Holmes A, Dai H, Manimtim WM. The impact of neurally adjusted ventilatory assist mode on respiratory severity score and energy expenditure in infants: a randomized crossover trial. J Perinatol. 2018 Jan;38(1):59-63. doi: 10.1038/jp.2017.154. Epub 2017 Oct 26.
PubMed 29072677

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

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
ClinicalTrials.gov ID: NCT02518230
Acronym / sponsor ID: Crossover NAVA
Conditions: Respiratory Insufficiency, Infant, Newborn, Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Study start: Jan 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 23 Jul 2021

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

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

Arm	Type	Receives
Neurally Adjusted Ventilatory Assist	Other	Device: Neurally Adjusted Ventilatory Assist, Device: Synchronized Interm. Mandatory AssistSubject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
Synchronized Interm. Mandatory Assist	Other	Device: Neurally Adjusted Ventilatory Assist, Device: Synchronized Interm. Mandatory AssistSubject will be randomized to SIMV(PC)PS ventilation. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.

Who may qualify

Ages: Up to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Neonates and infants, 22 weeks gestation age or older at birth
Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes
Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less.
Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.

Key exclusion criteria (6 listed)

Major congenital anomalies
Neurologic compromise of respiratory drive
Phrenic nerve palsy
Sedated enough to suppress respiratory drive
Respiratory support with volume mechanical ventilation

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
Neurally Adjusted Ventilatory AssistThe subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist	Device	Neurally Adjusted Ventilatory Assist, Synchronized Interm. Mandatory Assist
Synchronized Interm. Mandatory AssistThe subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support	Device	Neurally Adjusted Ventilatory Assist, Synchronized Interm. Mandatory Assist

Primary outcome

Respiratory Severity Score (MAP X FiO2)
Time frame: 12 hours and 24 hours
The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.

1 secondary outcome

Energy Expenditure
Time frame: 12 hours and 24 hours

Results and safety

Results posted to the registry on 23 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NAVA Ventilation First, Then SIMV(PC)PS Ventilation	11	11
SIMV(PC)PS Ventilation First, Then NAVA Ventilation	11	11

Primary outcome: Respiratory Severity Score (MAP X FiO2)

Time frame: 12 hours and 24 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	NAVA Ventilation First, Then SIMV(PC)PS Ventilation n = 11	SIMV(PC)PS Ventilation First, Then NAVA Ventilation n = 11
Respiratory severity score 12 h average	3.83 (2)	3.82 (1.79)
Respiratory severity score 24 h average	3.46 (2.24)	3.86 (1.93)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NAVA Ventilation First, Then SIMV(PC)PS Ventilation	0 of 11 (0%)	0 of 11 (0%)	0 of 11
SIMV(PC)PS Ventilation First, Then NAVA Ventilation	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29072677Rosterman JL, Pallotto EK, Truog WE, Escobar H, Meinert KA, Holmes A, Dai H, Manimtim WM. The impact of neurally adjusted ventilatory assist mode on respiratory severity score and energy expenditure in infants: a randomized crossover trial. J Perinatol. 2018 Jan;38(1):59-63. doi: 10.1038/jp.2017.154. Epub 2017 Oct 26.

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Not yet recruiting
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Not yet recruiting
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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.

Jamie L Rosterman, DO principal investigator

Children's Mercy Hospital Kansas City

1 site 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 6 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 Jul 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 United States. 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?

Yes. Results are posted in the registry (first posted 23 Jul 2021). 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?

Respiratory Severity Score (MAP X FiO2) (time frame: 12 hours and 24 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 NCT02518230, 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 Jul 2021.