Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03492307|
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) Other: Standard Flow for HFNC (Maximum 8L/minute)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Active Comparator: Standard Flow Protocol
Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.
Other: Standard Flow for HFNC (Maximum 8L/minute)
Maximum flow of 8L/minute.
Experimental: Weight-Based Flow Protocol
Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.
Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
A weight-based flow for HFNC.
- Treatment failure [ Time Frame: During hospital admission ]Need for escalation to NIV (CPAP or BIPAP) or intubation
- Length of Stay [ Time Frame: During hospital admission ]Length of hospital stay (admission to discharge or transfer)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492307
|Contact: Alla L Smith, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|South Shore Hospital||Recruiting|
|Weymouth, Massachusetts, United States, 02190|
|Contact: Alla Smith, MD|
|Principal Investigator:||Alla Smith, MD||Boston Children’s Hospital|