Status:
TERMINATED
Pediatric Helmet CPAP Pilot Study
Lead Sponsor:
Columbia University
Conditions:
Bronchiolitis, Viral
Pneumonia, Viral
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPA...
Detailed Description
Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in ...
Eligibility Criteria
Inclusion
- One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Exclusion
- Age less than 1 month or greater than 5 years
- Positive for COVID-19
- Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
- Unresponsiveness (GCS 8 or less)
- Hypotension as defined as a systolic blood pressure less than 5th percentile for age
- Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
- Non-English speaking parent
Key Trial Info
Start Date :
August 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04764929
Start Date
August 7 2021
End Date
June 14 2023
Last Update
July 29 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032