Recruiting

Observational Study

Sponsor:

Guilherme Sant'Anna, MD

Code:

NCT02723123

Conditions

Noninvasive Ventilation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Recording of cardio-respiratory signals

Study Details

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.

Conditions

Noninvasive Ventilation

Study ID

NCT02723123

Start date

Apr, 2016

Status verified date

Aug, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • birth weight under 1250 grams receiving invasive mechanical ventilation

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: CPAP

CPAP will be provided for a approximately 45 minutes.

experimental: NIPPV

NIPPV will be provided for a approximately 45 minutes.

experimental: NIV-NAVA

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

Interventions

Recording of cardio-respiratory signals

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

Primary outcome measure

  • Differences on cardiorespiratory behaviour in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA [ Time Frame: Immediate post-extubation period (30 minutes after extubation) ]

Central Contacts and Locations

Central contacts

Monica Bhuller, BSc.

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

Guilherme Sant'Anna, MD

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

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Guilherme Sant'Anna, MD, PhD

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

Wissam Shalish, MD

514-412-4452wissam.shalish@mail.mcgill.ca

More Information

Sponsor

Guilherme Sant'Anna, MD

Last update posted

Aug 22, 2018

Last verified

Aug, 2018

Keywords

  • CPAP
  • NIPPV
  • Extubation failure
  • Cardiorespiratory behaviour
  • NIV-NAVA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Guilherme Sant'Anna, MD on 2018-08-22.