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HFNC and NCPAP in Extremely Preterm Infants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03649282
Enrollment
30
Registered
2018-08-28
Start date
2013-10-31
Completion date
2016-04-30
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extreme Prematurity

Keywords

NCPAP, HFNC, Preterm infants, Cardiorespiratory behaviour, Non-invasive respiratory support

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.

Interventions

OTHERHFNC

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.

OTHERNCPAP

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.

Sponsors

Guilherme Sant'Anna, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAPImmediate post-extubation periodCardiac 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 NCPAPImmediate post-extubation periodRespiratory 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026