Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)
August 27, 2019 updated by: Christiana Care Health Services
Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19718
- Christiana Care Health Services, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Enrollment
|
All infants enrolled will have work of breathing assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intermittent hypoxia
Time Frame: 2 hours
|
Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelley Kovatis, MD, Christiana Care Health Services, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 15, 2018
Primary Completion (ACTUAL)
July 31, 2019
Study Completion (ACTUAL)
August 1, 2019
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (ACTUAL)
May 21, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 27, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- DDD603875
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.