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Non-invasive Ventilation for Extubation Success in Infants Less Than 1,250 Grams

NCT02051491 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-05-16

No results posted yet for this study

Summary

In preterm infants, endotracheal mechanical ventilation is well known to cause various forms of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and require intubation. A relatively recent mode of NIV is non-invasive high frequency ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be ventilated effectively. However, its efficacy in comparison with other existing modes of NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.

Conditions

Interventions

DEVICE

BP-NCPAP

Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm H2O and a higher level PEEP of 8 cm H2O at a cycle rate of 20 per minute with 1 second at the higher PEEP per cycle. The settings can then be adjusted and titrated up to a maximum of 7 and 10 cm H2O for the lower and higher PEEPs respectively at a maximum rate of 30 cycles per second based on FiO2 requirements.

DEVICE

NIHFV

The initial settings will be a MAP of 8 cm H2O, frequency of 10 Hz, and amplitude of 20 cm H2O. The maximum allowable MAP will be 10 cm of H2O. The range of frequency allowed will be 6 - 14 Hz. Both frequency and amplitude will be adjusted to try and achieve palpable/visible chest movement and to achieve target CO2 levels for the particular patient.

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Vibhuti Shah, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT02051491 on ClinicalTrials.gov