HFNC and NCPAP in Extremely Preterm Infants

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.

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Key information

Conditions

Extreme Prematurity

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Children's Hospital, Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HFNC

Other

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.

nCPAP

Other

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 outcomes

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

Time frame: Immediate post-extubation period

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

Time frame: Immediate post-extubation period

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.

Sponsors and collaborators

Lead sponsor

Guilherme Sant'Anna, MD

Other

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Aug 28, 2018
Registry last updated: Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed