NCT03649282

Brief Summary

To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

August 21, 2018

Last Update Submit

August 24, 2018

Conditions

Extreme Prematurity

Keywords

NCPAPHFNCPreterm infantsCardiorespiratory behaviourNon-invasive respiratory support

Outcome Measures

Primary Outcomes (2)

  • Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP

    Cardiac signals from the electrocardiogram will be continuously measured throughout the recordings. Analysis of these signals will be performed offline to calculate heart rate variability using linear and nonlinear methods.

    Immediate post-extubation period

  • Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP

    Respiratory variability will be calculated by using analysis of respiratory inductive pletysmography signals from the recordings during HFNC and NCPAP. Desaturation events will also be calculated from these recordings.

    Immediate post-extubation period

Study Arms (2)

HFNC/NCPAP

EXPERIMENTAL

HFNC will be provided for 45 minutes followed by NCPAP for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline.

Other: HFNCOther: NCPAP

NCPAP/HFNC

EXPERIMENTAL

NCPAP will be provided for 45 minutes followed by HFNC for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline.

Other: HFNCOther: NCPAP

Interventions

HFNCOTHER

HFNC therapy will be delivered with a system that provides heated, humidified high flow of gas through a tube that maintains the temperature and humidification. This intervention will involve the delivery of gas (air/oxygen) at a high flow rate, using an adequate nasal cannulae size and a cannula/nostril diameter ratio between 0.5-0.8.

HFNC/NCPAPNCPAP/HFNC
NCPAPOTHER

NCPAP will be provided as either bubble CPAP or through a ventilator, and will deliver a regulated pressure of gas (air/oxygen) to the patient through infant binasal prongs as interface. Nasal prong sizes will be chosen according to manufacturer recommendations.

HFNC/NCPAPNCPAP/HFNC

Eligibility Criteria

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

You may qualify if:

  • Infants with birth weight ≤ 1250 grams
  • Infants that have been mechanically ventilated and undergoing their first elective extubation attempt

You may not qualify if:

  • Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
  • Infants reintubated before initiation or during data collection.
  • Parental/legal guardian consent not obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Study Officials

  • Guilherme M Sant'Anna, MD, PhD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

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
Associate Professor, Department of Paediatrics, McGill University Health Center

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 28, 2018

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

April 1, 2016

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

CA(2)