NCT02723123

Brief Summary

Non-invasive respiratory support is routinely provided to extremely preterm infants following disconnection from mechanical ventilation, in the form of continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV). However, these modes remain sub-optimal due to lack of synchronization and upper airway defensive mechanisms that potentially hinder their effectiveness. Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) is a novel mode that may overcome some of these problems but has not been investigated in this population. Investigators hypothesize that there will be significant differences in cardiorespiratory behavior in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA during the immediate post-extubation period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

November 27, 2015

Last Update Submit

August 21, 2018

Conditions

Noninvasive Ventilation

Keywords

CPAPNIPPVExtubation failureCardiorespiratory behaviourNIV-NAVA

Outcome Measures

Primary Outcomes (1)

  • Differences on cardiorespiratory behaviour in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA

    Cardiorespiratory signals (ECG, thoraco-abdominal movements, oxygen saturation and TcPCO2), and ventilator signals (pressure and EAdi waveforms, tidal volume, MAP, PIP, PEEP, and FiO2) will continuously be measured throughout the recordings. Analysis of these signals will be performed offline. From these cardiorespiratory signals, behaviour will be analyzed by calculations of: cardiorespiratory variability, respiratory pauses, thoraco-abdominal asynchrony, respiratory movement artifacts and regular breathing pattern. Cardiorespiratory behavior will be calculated using the instantaneous power estimate of all respiratory and cardiac signals computed. To this end, each of the continuous metrics will be squared and averaged over a symmetric, two-sided window of length. For example, the correlation between respiratory and heart rates will be estimated by averaging the product fmax\*hmax over the same window.

    Immediate post-extubation period (30 minutes after extubation)

Secondary Outcomes (1)

  • Differences on in patient-ventilator interaction in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA

    Immediate post-extubation period (30 minutes after extubation)

Study Arms (3)

CPAP

EXPERIMENTAL

CPAP will be provided for a approximately 45 minutes.

Other: Recording of cardio-respiratory signals

NIPPV

EXPERIMENTAL

NIPPV will be provided for a approximately 45 minutes.

Other: Recording of cardio-respiratory signals

NIV-NAVA

EXPERIMENTAL

NIV-NAVA will be provided for a approximately 45 minutes.

Other: Recording of cardio-respiratory signals

Interventions

Recording of cardio-respiratory signalsOTHER

Biological signals: ECG, RIP, SpO2 and Pulse rate will be recorded during the interventions and analyzed offline.

CPAPNIPPVNIV-NAVA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • birth weight under 1250 grams receiving invasive mechanical ventilation

You may not qualify if:

  • infants with major congenital anomalies, congenital heart defects, neuromuscular disease, diaphragmatic paralysis or palsy, diagnosed phrenic nerve injury, esophageal perforation, hemodynamic instability as well as infants on interpose, narcotics or sedative agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Study Officials

  • Guilherme Sant'Anna, MD

    McGill University

    STUDY CHAIR

  • Wissam Shalish, MD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Robert Kearney, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Karen Brown, MD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Doina Precup, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Bhuller, BSc.

CONTACT

514-705-2288monica.bhuller@mail.mcgill.ca

Guilherme Sant'Anna, MD

CONTACT

514-412-4400guilherme.santanna@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Paediatrics

Study Record Dates

First Submitted

November 27, 2015

First Posted

March 30, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

CA(1)