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NCT03529994 Clinical Trial

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

High Flow Nasal Cannula Clinical Trial

Official title:
Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03529994
Other study ID # DDD603875
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2018
Est. completion date August 1, 2019

Study information
Verified date May 2019
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 1, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Enrollment
All infants enrolled will have work of breathing assessed.

Locations
Country Name City State
United States Christiana Care Health Services, Inc. Newark Delaware

Sponsors (2)
Lead Sponsor Collaborator
Christiana Care Health Services Alfred I. duPont Hospital for Children

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Work of breathing indices Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency. 2 hours
Secondary Intermittent hypoxia Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency. 2 hours
See also
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Completed NCT02793674 - HFNC Flow Titration and Effort of Breathing in the PICU N/A
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Not yet recruiting NCT04293991 - High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure N/A
Recruiting NCT06306651 - High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea N/A
Completed NCT02958488 - Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks) N/A
Completed NCT03845244 - Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy N/A
Completed NCT04965844 - Closed-loop Oxygen Control for High Flow Nasal Therapy N/A
Not yet recruiting NCT05467332 - Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.
Completed NCT04325906 - Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS N/A