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

NCT02051491 | Unknown

• 1 other identifier: 12-0276A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP

  72 hours

Secondary Outcomes (10)

• Intubation rates at 72 hours and 7 days post randomization

  7 days

• Comparison of the number of apneic spells

  7 days

• PaCO2 levels at time of initiation

  2 hours

• Total number of days on Endotracheal Mechanical Ventilation

  2 months

• Rates of adverse outcomes between the 2 groups

  2 months

Study Arms (2)

BP-NCPAP

ACTIVE COMPARATOR

Nasal BP-NCPAP will be delivered using the Infant Flow® SiPAP™ and either nasal prongs or mask interface. A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with transcutaneous carbon dioxide (TcCO2) monitor data (if available). Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm water (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 fraction of inspired oxygen (FiO2) requirements.

Device: BP-NCPAP

NIHFV

EXPERIMENTAL

NIHFV will be provided using the Drager VN500, using either nasal prong or mask interfaces.A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with TcCO2 monitor data (if available). Initial settings for NIHFV arm will be 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.

Device: NIHFV

Interventions

BP-NCPAP DEVICE

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.

Also known as: InfantFlow® SiPAP™

BP-NCPAP

NIHFV DEVICE

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.

Also known as: Drager VN500

NIHFV

Eligibility Criteria

• Age: 72 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 72 hours post-natal age AND currently on NCPAP
• Less than 1,250 g when on NCPAP at time of enrollment

You may not qualify if:

• Congenital or acquired abnormality of upper airways
• Severe congenital anomalies including cyanotic congenital heart disease
• Severe nasal excoriation/injury preventing use of NIV interface
• Greater than 2,000 grams at time of randomization

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (1)

• Mukerji A, Sarmiento K, Lee B, Hassall K, Shah V. Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial. J Perinatol. 2017 Jan;37(1):49-53. doi: 10.1038/jp.2016.172. Epub 2016 Sep 29.

  PMID: 27684415 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Vibhuti Shah, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibhuti Shah, MD

CONTACT

1-416-586-4816; vshah@mtsinai.on.ca

Amit Mukerji, MD

CONTACT

416-320-7716; amit.mukerji@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neonatologist, Mount Sinai Hospital

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: January 31, 2014
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

CA (1)