HFNC and NCPAP in Extremely Preterm Infants

NCT03649282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-28

No results posted yet for this study

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.

Conditions

  • Extreme Prematurity

Interventions

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.

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.

Sponsors & Collaborators

  • Guilherme Sant'Anna, MD

    lead OTHER

Principal Investigators

  • Guilherme M Sant'Anna, MD, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-08-31
Completion
2016-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649282 on ClinicalTrials.gov