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HFNC and NCPAP in Extremely Preterm Infants

Primary Purpose

Extreme Prematurity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HFNC
NCPAP
Sponsored by
Guilherme Sant'Anna, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Extreme Prematurity focused on measuring NCPAP, HFNC, Preterm infants, Cardiorespiratory behaviour, Non-invasive respiratory support

Eligibility Criteria

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Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Montreal Children's Hospital
  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HFNC/NCPAP

NCPAP/HFNC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2018
Last Updated
August 24, 2018
Sponsor
Guilherme Sant'Anna, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03649282
Brief Title
HFNC and NCPAP in Extremely Preterm Infants
Official Title
Comparisons of the Dynamic of the Cardiorespiratory System Behavior of Extreme Preterm Infants Receiving Nasal CPAP or High Flow Nasal Cannula During the Immediate Post-extubation Period
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guilherme Sant'Anna, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extreme Prematurity
Keywords
NCPAP, HFNC, Preterm infants, Cardiorespiratory behaviour, Non-invasive respiratory support

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC/NCPAP
Arm Type
Experimental
Arm Description
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.
Arm Title
NCPAP/HFNC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HFNC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NCPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP
Description
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.
Time Frame
Immediate post-extubation period
Title
Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP
Description
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.
Time Frame
Immediate post-extubation period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants with birth weight ≤ 1250 grams Infants that have been mechanically ventilated and undergoing their first elective extubation attempt Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme M Sant'Anna, MD, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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HFNC and NCPAP in Extremely Preterm Infants

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