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Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529994
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
Christiana Care Health Services

Brief Summary:
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.

Condition or disease Intervention/treatment
High Flow Nasal Cannula Other: Enrollment

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Enrollment Other: Enrollment
All infants enrolled will have work of breathing assessed.




Primary Outcome Measures :
  1. Work of breathing indices [ Time Frame: 2 hours ]
    Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.


Secondary Outcome Measures :
  1. Intermittent hypoxia [ Time Frame: 2 hours ]
    Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.
Criteria

Inclusion Criteria:

  • Infants between 27 and 37 weeks corrected gestational age
  • >4 days PNA
  • Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
  • Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study

Exclusion Criteria:

  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements

Information from the National Library of Medicine

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): NCT03529994


Locations
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United States, Delaware
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Investigators
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Principal Investigator: Kelley Kovatis, MD Christiana Care Health Services, Inc.
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Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT03529994    
Other Study ID Numbers: DDD603875
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes