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

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

• Status: Completed
• Conditions: High Flow Nasal Cannula
• Intervention / Treatment: Other: Enrollment

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services, Inc.

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrollment	Other: 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	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	Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.	2 hours

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: Alfred I. duPont Hospital for Children
• Investigators: Principal Investigator: Kelley Kovatis, MD, Christiana Care Health Services, Inc.

Study record dates

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