HFNC and NCPAP in Extremely Preterm Infants

Extreme Prematurity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649282
• Other study ID #: 12-342-PED
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Extreme Prematurity

Intervention

Other:
• HFNC
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
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.

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Guilherme Sant'Anna, MD

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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