Does NIV-NAVA Improve Diaphragmatic Function in Preterm Infants

March 15, 2023 updated by: Adel Mohamed, Mount Sinai Hospital, Canada

Does Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) Improve Diaphragmatic Function in Preterm Infants?

Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD.

Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.

Study Overview

Status

Status

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

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

STUDY POPULATION Premature infants with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported with NIPPV or NIV-NAVA.

Inclusion criteria

  1. Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
  2. Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.

Exclusion criteria

  1. Infants with congenital anomalies.
  2. Infants with known genetic disorder.
  3. Infants with known lung malformation or diaphragm dysfunction.
  4. Infants of whom parents declined consent.

Study Design and settings:

This is a prospective cohort study that includes premature infants born at 22 0/7 to 29 6/7 weeks GA in Mount Sinai Hospital and admitted to the NICU. Written consent will be obtained from parents or guardians prior to enrolment in the study. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent. Recruitment will be done over one year, and the investigators are expecting to recruit about 30 infants in the NIPPV group and similar number in the NIV-NAVA group.

Time of assessment; Eligible infants will be identified by a member of the infant's circle of care. Parents of infants who are eligible for the study will be approached for consent. Chest ultrasound (lung ultrasound and diaphragmatic function assessment) will be performed at > 7 days postnatally, provided that the infant is supported by either NIPPV or NIV-NAVA for at least 24 hours. CUS will be done prior to feeding to avoid any concerns of a full stomach on diaphragmatic assessment.

Study procedure: Functional assessment of the diaphragm combined with lung ultrasound examination will be done by one of the investigators.

Lung ultrasound assessment technique; Lung ultrasounds will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 3 points with a total score between 0 to 18, which inversely correlates with lung aeration.

Diaphragmatic assessment technique; Diaphragm assessment will be performed in the supine position. To measure diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side and between the anterior and mid-axillary lines for the left side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of the right hemidiaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.

The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness fraction will be calculated using the following formula:

diaphragmatic thickness fraction = [(inspiratory thickness - expiratory thickness)/expiratory thickness] x 100.

The average of the calculated diaphragmatic thickness fraction from three respiratory cycles will be estimated. The higher scores the better the diaphragmatic function. All Chest ultrasound assessments will be undertaken using a standard aseptic technique.

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 (Actual)

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital

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

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants that were born between 22 0/7 to 29 6/7 weeks gestation and were admitted to the NICU at Mount Sinai Health System will be eligible for the study. Infants will be enrolled after obtaining parents' consent and Research Ethics Board approval

Description

Inclusion criteria

  1. Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
  2. Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.

Exclusion Criteria:

  1. Infants with congenital anomalies.
  2. Infants with known genetic disorder.
  3. Infants with known lung malformation or diaphragm dysfunction.
  4. Infants of whom parents declined consent.

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: Cohort
  • 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.
NIV-NAVA group
Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIV-NAVA for at least 24 hours are enrolled in this arm after obtaining parents' consent.
Other: Chest ultrasound
Chest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
NIPPV group
Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIPPV for at least 24 hours are enrolled in this arm after obtaining parents' consent.
Other: Chest ultrasound
Chest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.

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
Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time Frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Thickness (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
1 YEAR
Evaluation of the diaphragmatic excursion (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time Frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Excursion (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
1 YEAR

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
Lung ultrasound score for infants in NIV-NAVA group vs NIPPV group
Time Frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Lung ultrasound score will performed. Lung ultrasound score range from 0 to 18 points. while 0 points (good score) means normal lung, 18 points (bad score) mean severely affected lung. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
1 YEAR

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.
Mount Sinai Hospital, Canada

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: Adel Mohamed, MD, Mount Sinai Hospital- Toronto, ON, Canada

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.
February 1, 2021

Primary Completion (Actual)

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 30, 2022

Study Completion (Actual)

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.
October 30, 2022

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).
September 30, 2021

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 12, 2021

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 15, 2021

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 16, 2023

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 15, 2023

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.
March 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 19-0324-E

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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