Study Stopped
Poor recruitment rate
NHFOV Versus NCPAP to Prevent Exubation Failure
Nasal High Frequency Oscillatory Ventilation (NHFOV) Versus Nasal Continuous Positive Airway Pressure (NCPAP) Ventilation: a Pilot Trial
1 other identifier
interventional
20
1 country
2
Brief Summary
The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and mechanical ventilation in preterm infants less than 28 weeks gestation following first attempt at extubation and removal from mechanical ventilation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 5, 2015
August 1, 2015
2.2 years
April 17, 2013
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extubation failure
Newborns in both groups will be re-intubated within the study period if they have respiratory failure defined as arterial or capillary gas with pH \< 7.20 or PCO2 \> 60, oxygen requirement ≥ 35%, or recurrent or severe apnea (12 documented apneas within 24 hours or single apnea requiring positive pressure ventilation).
within 7 days post-extubation
Secondary Outcomes (4)
Changes in capillary pCO2 after extubation
Within 7 days post-extubation
pneumothorax
duration of use of positive pressure or reintubation which ever is shorter
intraventricular hemorrage (IVH)
first 2 weeks of life
feeding tolerance
3 weeks
Study Arms (2)
Nasal CPAP
ACTIVE COMPARATORNasal CPAP using Infant flow
NHFOV
EXPERIMENTALNasal High Frequency Oscillatory Ventilation using Dräger Babylog® VN500 ventilator machine
Interventions
Eligibility Criteria
You may qualify if:
- Newborn less than 28 weeks gestation at birth
- Intubated and ventilated in the first 24 hours of life
- Extubated in the first week of life
- Parental consent
You may not qualify if:
- Lack of parental consent
- Major congenital malformation
- Severe perinatal asphyxia
- Airway abnormalities
- Pneumothorax
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Health Sciences Center, NICU
Winnipeg, Manitoba, R3A 1S1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald J Baier, M.D.
HSC Neonatology
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
- Fellow, Neonatal-Perinatal Medicine
Study Record Dates
First Submitted
April 17, 2013
First Posted
May 14, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 5, 2015
Record last verified: 2015-08