HFNC and NCPAP in Extremely Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Extreme Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HFNC/NCPAP

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.

Group Type EXPERIMENTAL

HFNC

Intervention Type 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

Intervention Type 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.

NCPAP/HFNC

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.

Group Type EXPERIMENTAL

HFNC

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No