TerminatedNot Applicable

Pediatric Helmet CPAP Pilot Study

Stopped: Investigators left the institution

United States5 participantsStarted 2021-08-07

Plain-language 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. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.

Who can participate

Age range1 Month – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours

Timeframe: Four hours

Trial details

NCT IDNCT04764929

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-19

Results submitted2024-05-21